| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K230459 |
02/21/2023 |
C.C. Life 21 |
21 Equipment S.R.L. |
Dolores Moretto |
| K234043 |
12/21/2023 |
3MÖ TransbondÖ Orthodontic Adhesive |
3M Unitek Orthodontic Products |
Chandrapaul Parsram |
| K233966 |
12/15/2023 |
Anterior Spine Truss System-Stand Alone (ASTS-SA) |
4WEB Medical, Inc. |
Richard Jansen |
| K233861 |
12/06/2023 |
Libre Rio Continuous Glucose Monitoring System |
Abbott Diabetes Care |
Tenzin Ngadon |
| K233932 |
12/14/2023 |
Alinity i Toxo IgM |
Abbott Laboratories |
Laura Fraczek |
| K230286 |
02/02/2023 |
Assert-IQÖ Insertable Cardiac Monitor |
Abbott Medical |
Laura Sparks |
| K234118 |
12/28/2023 |
CentriMagÖ Acute Circulatory Support System |
Abbott Medical |
Bendre Ketaki |
| K230411 |
02/15/2023 |
Dragonfly OpStarÖ Imaging Catheter |
Abbott Medical |
Derek Pike |
| K230283 |
02/01/2023 |
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 4 |
Abbott Medical |
Chidalu Mozie |
| K234143 |
12/29/2023 |
i-STAT TBI Cartridge with the i-STAT Alinity System |
Abbott Point of Care |
Brian Ma |
| K230285 |
02/02/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc |
Jacquelyn Gesumaria |
| K230275 |
02/01/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Brian Ma |
| K230300 |
02/03/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Brian Ma |
| K234123 |
12/28/2023 |
Easi-Vue« embolic microspheres System |
ABK Biomedical Inc |
Brandi Woods |
| K234152 |
12/29/2023 |
ACESO Early Pregnancy Test |
Aceso Laboratories, Inc. |
Yinfei Wu |
| K230532 |
02/27/2023 |
RADx Intraoral Appliance for Snoring and Sleep Apnea |
Achaemenid LLC |
Rachel Miller |
| K233904 |
12/11/2023 |
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ |
Acist Medical Systems, Inc |
Bobbie Daughters |
| K230478 |
02/22/2023 |
Acro Composites Interbody System |
Acro Composites, LLC |
Mitchell Bass |
| K234082 |
12/22/2023 |
STERRAD« 100NX Sterilizer with ALLClearÖ Technology and ULTRA GIÖ Cycle (10104); APTIMAXÖ Instrument Tray for ULTRA GIÖ Cycle (011077) |
Advanced Sterilization Products |
Ayse Erkan |
| K234084 |
12/22/2023 |
STERRADÖ Chemical Indicator (CI) Strip (14100); STERRAD« SEALSURE« Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITYÖ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITYÖ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITYÖ |
Advanced Sterilization Products, Inc. |
Brandon Roberts |
| K230534 |
02/27/2023 |
BriefCase-Quantification |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K233998 |
12/18/2023 |
TRAQinform IQ |
AIQ Global, Inc. |
Dona Alberti |
| K234141 |
12/29/2023 |
AISAP Cardio V1.0 |
Aisap |
Robert Klempfner |
| K233974 |
12/15/2023 |
Mucosal Impedance Measurement System |
Alandra Medical SAPI de CV |
Montserrat Godinez Garcia |
| K233876 |
12/07/2023 |
UNITY VCS (8065000296); UNITY CS (8065000297) |
Alcon Laboratories Inc. |
Ganesh Balachandar |
| K233902 |
12/11/2023 |
CenturionÖ Vision System (Active SentryÖ) (8065753057) |
Alcon Laboratories, Inc. |
De Rama Rita |
| K233856 |
12/05/2023 |
Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K234115 |
12/27/2023 |
APRO 55 Catheter |
Alembic, LLC |
Lisa Yen |
| K230383 |
02/13/2023 |
Savvy Surgical Mask - Level 3 |
ALG Health LLC |
Doug Soper |
| K234006 |
12/19/2023 |
AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test |
AllSource Screening Solutions |
Peter O'Connor |
| K230371 |
02/13/2023 |
The Alma Soprano Titanium |
Alma Lasers Inc. |
Jessica Rivera-Montejo |
| K230308 |
02/03/2023 |
Alma Harmony |
Alma Lasers, Inc. |
Jessica Rivera Montejo |
| K234092 |
12/26/2023 |
SafeOp 3: Neural Informatix Systeem |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K230428 |
02/17/2023 |
Ambu« aScopeÖ 5 Broncho 2.7/1.2, Ambu« aScopeÖ 5 Broncho 4.2/2.2, Ambu« aBoxÖ 2 |
Ambu A/S |
Karina Matthiesen |
| K230332 |
02/07/2023 |
Ambu« aScopeÖ Colon; Ambu« aBoxÖ 2 |
Ambu A/S |
Mette Andersen |
| K233886 |
12/08/2023 |
Ambu« aScopeÖ Duodeno 2, Ambu« aBoxÖ 2 |
Ambu A/S |
Mette Andersen |
| K230340 |
02/07/2023 |
Lucas Plus |
AMT Engineering Co., Ltd |
SeoungSoo Choi |
| K234041 |
12/21/2023 |
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Ful |
Andon Health Co Ltd |
Yi Liu |
| K234024 |
12/20/2023 |
HWJECT Auto-disable syringe |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
Bingyi Xiang |
| K233913 |
12/12/2023 |
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) |
AOJ Health Technology Co., Ltd. |
Jack Wang |
| DEN230081 |
12/04/2023 |
Hearing Aid Feature (HAF) |
Apple Inc. |
Kevin Go |
| K233987 |
12/18/2023 |
VERABANDÖ |
Arbor Medical Innovations, LLC |
Grant Kruger |
| K233909 |
12/12/2023 |
CleanerÖ Plus 18F Thrombectomy System - CleanerÖ Plus 18F Aspiration Catheter, CleanerÖ Plus 18F Handpiece with Maceration Wire, CleanerÖ Plus 18F Aspiration Canister |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K230370 |
02/10/2023 |
SpotLight/SpotLight Duo (with DLIR option) |
Arineta Ltd. |
Tanya Shalem |
| K230303 |
02/03/2023 |
AccuFFRangio Plus |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K230513 |
02/24/2023 |
Arthrex Univers Apex OptiFit Humeral Stem |
Arthrex Inc |
Tiffany Mentzel |
| K230433 |
02/17/2023 |
Arthrex Knotless FiberTak Suture Anchor |
Arthrex Inc. |
Kelsey Roberts |
| K230366 |
02/10/2023 |
Arthrex Univers Revers Monoblock Stem Size 4/33 |
Arthrex Inc. |
Tiffany Mentzel |
| K230435 |
02/17/2023 |
Arthrex 3.9 mm SwiveLock Anchor |
Arthrex, Inc. |
Stacy Valdez |
| K233971 |
12/15/2023 |
Arthrex AlloSync PushLock Suture Anchor |
Arthrex, Inc. |
Emmarie Halteman |
| K234112 |
12/27/2023 |
Customized Abutment |
Arum Dentistry Co., Ltd. |
Boyeon Lim |
| K230377 |
02/13/2023 |
CROSSLEAD Penetration Peripheral Guide Wire |
ASAHI INTECC Co., Ltd. |
Katsuhiko Fujimura |
| K233866 |
12/06/2023 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Madhuvanthi Soundirarajan |
| K234151 |
12/29/2023 |
Isolator Synergy EnCapture Ablation System (EMH) |
AtriCure Inc. |
Dominique Neisz |
| K234125 |
12/28/2023 |
AtriClip FLEX-Mini LAA Exclusion System (ACHM) |
AtriCure, Inc. |
Stephanie Hadnot |
| K233959 |
12/15/2023 |
EPi-Ease Epicardial Access Device (EAS) |
AtriCure, Inc. |
Jenifer Ulrikson |
| K233968 |
12/15/2023 |
CINA-iPE |
Avicenna.AI |
Stephane Berger |
| K230492 |
02/23/2023 |
Avitus« Precision Autograft Delivery System |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K233954 |
12/15/2023 |
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu |
B&E Korea Co., Ltd. |
Jayong Shin |
| K234074 |
12/22/2023 |
Next Generation Access Catheter |
Balt USA, LLC |
Catherine Chiou |
| K234083 |
12/22/2023 |
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set |
Balt USA, LLC |
Alicia Smith |
| K230520 |
02/27/2023 |
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) |
Barco NV |
Julie Vandecandelaere |
| K230319 |
02/06/2023 |
Passio Pump Drainage System |
Bearpac Medical |
Jay Zimmerman |
| K234005 |
12/19/2023 |
Access CK-MB |
Beckman Coulter, Inc |
Neha Desai |
| K234052 |
12/21/2023 |
Access Ferritin |
Beckman Coulter, Inc |
Kate Oelberg |
| K230493 |
02/23/2023 |
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube |
Becton Dickinson and Company |
Katherine Kenner Lemus |
| K230391 |
02/14/2023 |
BD MiniDrawÖ Capillary Blood Collection System with BD MiniDrawÖ SSTÖ Capillary Blood Collection Tube |
Becton Dickinson and Company |
Katherine Kenner Lemus |
| K233986 |
12/18/2023 |
BD PhoenixÖ Automated Microbiology System - GN Ciprofloxacin (0.0156û4 ╡g/mL) |
Becton, Dickinson and Company |
Kamisha Gray |
| K234110 |
12/27/2023 |
Belun Ring BLR-200 (BLR-200) |
Belun Technology Company Limited |
Lap Wai Lydia Leung |
| K233872 |
12/07/2023 |
Daylight |
Big Health, Inc. |
Reuben Lawson |
| K230404 |
02/15/2023 |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K234012 |
12/19/2023 |
VITEK COMPACT PRO |
bioMerieux Inc. |
Craig Buehler |
| K234000 |
12/18/2023 |
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 ╡g/mL) |
bioMerieux, Inc. |
Anne Rasponi |
| K230540 |
02/27/2023 |
Patient Specific Planning SolutionÖ 3D Bone Models |
Biomet Manufacturing Corp. |
Katherine Choi |
| K230375 |
02/13/2023 |
BIOMONITOR IV |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K234145 |
12/29/2023 |
ViSiGi 3D Gastric Sizing Tube |
Boehringer Laboratories |
Nathan Simasek |
| K234033 |
12/20/2023 |
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) |
Boehringer Laboratories LLC |
Ondrej Nikel |
| DEN230015 |
02/17/2023 |
Osteoboost Belt |
Bone Health Technologies, Inc |
Laura Yecies |
| K234013 |
12/19/2023 |
Mg OSTEOINJECTÖ; Mg OSTEOREVIVEÖ; Mg OSTEOCRETEÖ |
Bone Solutions, Inc. |
Drew Diaz |
| K234008 |
12/19/2023 |
CERAMENT G |
BoneSupport AB |
Blerta Shuka |
| K234002 |
12/19/2023 |
ICEfx Cryoablation System (FPRCH8000-02) |
Boston Scientific |
Benjamin Van Santen |
| K230503 |
02/24/2023 |
Polaris XÖ Catheter Cable, BlazerÖ Dx-20 Catheter Cable |
Boston Scientific |
Stephanie Andre |
| K233939 |
12/14/2023 |
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System |
Boston Scientific |
Yanine Garcia-Quezada |
| K233837 |
12/04/2023 |
Agile Esophageal Stent System |
Boston Scientific Corporation |
Alexis Erazo |
| K230453 |
02/21/2023 |
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter |
Boston Scientific Corporation |
Cassie Clark |
| K230551 |
02/28/2023 |
Visual-ICE Cryoablation System |
Boston Scientific Corporation |
Amy McKinney |
| K234046 |
12/21/2023 |
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Deli |
Boston Scientific Corporation |
Tijana Prodanovic |
| K234047 |
12/21/2023 |
Automatic Registration |
Brainlab AG |
Esther Moreno Garcia |
| K233875 |
12/07/2023 |
Brainomix 360 e-Lung |
Brainomix Limited |
Thais Sala |
| K230467 |
02/21/2023 |
BTL-899F |
BTL Industries Inc. |
David Chmel |
| K233849 |
12/05/2023 |
BTL-499 |
BTL Industries, Inc. |
David Chmel |
| K230356 |
02/09/2023 |
AspirexÖ Thrombectomy System |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K230415 |
02/16/2023 |
Cadwell Guardian |
Cadwell Industries, Inc. |
Jason Ford |
| K233972 |
12/15/2023 |
Camber Sacroiliac (SI) Fixation System |
Camber Spine Technologies |
Brooks McAdam |
| K234077 |
12/22/2023 |
SPIRA« Anterior Lumbar Spacers |
Camber Spine Technologies |
Brooks McAdam |
| K234056 |
12/22/2023 |
canturio« se (Canturio Smart Extension) |
Canary Medical USA LLC |
Kevin Leung |
| K230355 |
02/09/2023 |
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K233989 |
12/18/2023 |
CarboClear« Posterior Cervical Screw System |
CarboFix Orthopedics Ltd. |
Batya Cohen |
| K233944 |
12/14/2023 |
CarboClear« X Pedicle Screw System; CarboClear« X Navigated Instruments |
CarboFix Orthopedics, Ltd. |
Hila Wachsler-Avrahami |
| K233911 |
12/12/2023 |
VISULAS combi |
Carl Zeiss Meditec AG |
Ling Ren |
| K233933 |
12/14/2023 |
CIRRUSÖ HD-OCT Model 6000 |
Carl Zeiss Meditec Inc |
Vidita Desai |
| K230350 |
02/09/2023 |
VISULAS yag |
Carl Zeiss Meditec Inc |
Tanesha Bland |
| K234105 |
12/26/2023 |
Catalyst F1x Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K234037 |
12/21/2023 |
CATS-L TonometerÖ Prism |
CATS Tonometer, LLC |
Sean McCafferty |
| K234029 |
12/20/2023 |
CEFALY Connected - OTC, CEFALY Connected - Rx |
CEFALY Technology |
Jennifer Trainor |
| K230309 |
02/03/2023 |
Intra-Operative Positioning System (IOPS«) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) |
Centerline Biomedical, Inc. |
Amanda Shade |
| K230363 |
02/10/2023 |
CPS Locator 3D Delivery Catheter |
CenterPoint Systems LLC |
Marybeth Gamber |
| K234076 |
12/21/2023 |
iCare ALTIUS CW |
Centervue Spa |
Luca Scienza |
| K230440 |
02/21/2023 |
Xpert« Xpress CoV-2 plus |
Cepheid« |
Suzette Chance |
| K233982 |
12/18/2023 |
CEREGLIDE 92 Catheter System |
Cerenovus Inc. |
Niall Fox |
| K233988 |
12/18/2023 |
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set |
Cerenovus, Inc. |
Ryan Rivera |
| K230456 |
02/21/2023 |
SGM Femoral Nail System |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K230524 |
02/27/2023 |
Cold Compression Wrap Pro |
Chengdu Cryo-Push Medical Technology Co.,Ltd |
Zhang Peiyong |
| K234003 |
12/19/2023 |
The Circadia C200 System |
Circadia Technologies, Ltd. |
Erhan Ilhan |
| K233955 |
12/15/2023 |
Clarius OB AI |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K234030 |
12/20/2023 |
Clear Guide SCENERGY |
Clear Guide Medical |
Alican Demir |
| K230277 |
02/01/2023 |
Pulse Oximeter(Model OHT60,OXH78) |
Cofoe Medical Technology Co., Ltd. |
Yang Cui |
| K233908 |
12/12/2023 |
cNeuro cDAT |
Combinostics Oy |
Lennart Thurfjell |
| K230547 |
02/28/2023 |
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter |
ConMed Corporation |
Ali AbuSaleh |
| K230400 |
02/15/2023 |
Cure Catheter Closed System; Cure Dextra Closed System |
ConvaTec, Inc. |
Courtney Smith |
| K234127 |
12/28/2023 |
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker |
CooperVision, Inc. |
Sahana Rajashekar |
| K230318 |
02/06/2023 |
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring |
Corcym S.r.l. |
Silvia Contadini |
| K230329 |
02/06/2023 |
F3D Interbody System |
Corelink, LLC |
Steven Mounts |
| K233976 |
12/15/2023 |
VasoGuard (V10, V8, V6, V4, V2) |
CorVascular Diagnostics, LLC |
Spencer Lien |
| K233964 |
12/15/2023 |
GI GeniusÖ Module 100 (GGM100.US); GI GeniusÖ Module 200 (GGM200.US); ColonPROÖ 4.0 (CPRO40.US) |
Cosmo Artificial Intelligence - AI Ltd |
Nhan Ngo Dinh |
| K230328 |
02/06/2023 |
Speedboat Flush SB1 Instrument |
Creo Medical Ltd |
Diane Davis |
| K230381 |
02/13/2023 |
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator |
CS Medical LLC |
Kendall Ashe |
| K233947 |
12/14/2023 |
KLIMTÖ Expandable Lumbar Interbody Fusion (LIF) Cage System |
CTL Medical Corporation |
Sean Suh |
| K230533 |
02/27/2023 |
MotiveÖ Electrode |
CyMedica Orthopedics, Inc. |
Kereshmeh Shahriari |
| K230510 |
02/24/2023 |
MyEllevate |
Cynosure, LLC |
Cynthia Aguirre |
| K230382 |
02/13/2023 |
3 Series NeoLux |
Daavlin Distributing Co. |
Michele Thiel |
| K230448 |
02/21/2023 |
DeepX DermoSight Dermatoscope |
DeepX Health LLC |
Laurens Kraal |
| K233952 |
12/15/2023 |
DEKA ACE Pump System |
Deka Research and Development |
Paul Smolenski |
| K234055 |
12/22/2023 |
DEKA Loop |
Deka Research and Development |
Paul Smolenski |
| K230341 |
02/08/2023 |
ACRIFIX |
DeltaMed GmbH |
Michael Zimmermann |
| K230410 |
02/15/2023 |
DD medical polymers (PMMA) |
Dental Direkt GmbH |
Patrick Berz |
| K230307 |
02/03/2023 |
Dentis i-Clean System |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K233921 |
12/13/2023 |
Luvis Chair (LC700C) |
DENTIS CO., LTD. |
Kim Kaon |
| K230523 |
02/27/2023 |
s-Clean Link Abutment Narrow |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K234018 |
12/20/2023 |
CEREC Cercon 4DÖ Abutment Blocks, CEREC Cercon 4DÖ Abutment System |
Dentsply Sirona |
Rebecca Sporer |
| K233865 |
12/06/2023 |
X-Smart Pro; X-Smart Pro+ |
Dentsply Sirona Inc. |
Laura Sorbin |
| K233980 |
12/18/2023 |
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System |
DePuy Ireland UC |
Meagan Robles |
| K230295 |
02/02/2023 |
ATTUNE« Revision Cones |
DePuy Ireland UC |
Kathy Boggs |
| DEN230008 |
02/02/2023 |
DermaSensor |
DermaSensor Inc. |
Cody Simmons |
| K234133 |
12/29/2023 |
Dexcom G7 Continuous Glucose Monitoring System |
Dexcom Inc. |
Neeta Sharma |
| K234070 |
12/22/2023 |
Stelo Glucose Biosensor System |
Dexcom, Inc. |
Neeta Sharma |
| DEN230092 |
12/28/2023 |
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) |
DiaSorin Molecular LLC |
Michele Chwedoruk |
| DEN230084 |
12/15/2023 |
Dexter L6 System |
Distalmotion, SA |
Larry Carrier |
| K230490 |
02/23/2023 |
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT |
Dongguan Hunter Electronic Technology Co., Ltd. |
Hunter Ye |
| K230379 |
02/13/2023 |
Portable (Ultrasonic) Nebulizer |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Jack Jin |
| K230374 |
02/13/2023 |
Coronary Dilatation Balloon Catheter (VesPenetrator«), Coronary Dilatation Balloon Catheter (VesTraveler«), Coronary Dilatation Balloon Catheter (VexPander«) |
Dongguan TT Medical, Inc |
Yuying Bi |
| K230278 |
02/01/2023 |
Babyroo TN300 |
Draeger Medical Systems, Inc. |
Karl Nittinger |
| K233834 |
12/04/2023 |
Infinity Gateway Suite |
Draeger Medical Systems, Inc. |
Chris Riel |
| K230395 |
02/14/2023 |
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) |
DURIO PPE SDN BHD |
Xavier Kong |
| K230337 |
02/07/2023 |
EarliPoint |
EarliTec Diagnostics, Inc |
Ryan Bormann |
| K233826 |
12/01/2023 |
Kosmos |
EchoNous, Inc. |
Joshua Kim |
| K233846 |
12/04/2023 |
Vitrification Solution Set and Warming Solution Set |
ECMPC, LLC |
Jose Gaytan Melicoff |
| K234129 |
12/28/2023 |
Ecomed Disposable Administration Sets |
Ecomed Solutions, LLC |
David Yurek |
| K234153 |
12/29/2023 |
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) |
EdgeLife Technologies LLC |
Quinn Place |
| K233895 |
12/11/2023 |
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and |
Edwards Lifesciences |
Peter Lindwall |
| K233820 |
12/01/2023 |
Fogarty Arterial Embolectomy Catheter with Gate Valve |
Edwards Lifesciences |
Yagna Angirish |
| K233983 |
12/18/2023 |
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) |
Edwards Lifesciences |
Anna Hwang |
| K233824 |
12/01/2023 |
Swan-Ganz catheter |
Edwards Lifesciences LLC |
Bedalin Lugo Rodriguez |
| K233984 |
12/18/2023 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences, LLC |
Kshama Pai |
| K233819 |
12/01/2023 |
Fogarty Venous Thrombectomy Catheters |
Edwards Lifesciences, LLC |
Unji Lee |
| K234057 |
12/22/2023 |
NIRVANA |
El.En. S.p.A. |
Paolo Peruzzi |
| K230460 |
02/21/2023 |
Laser Thermal Therapy Kit |
Elesta SPA |
Fabio Andreola |
| K230317 |
02/06/2023 |
Elos Accurate Hybrid Base |
Elos Medtech Pinol A/S |
Lise Terkelsen |
| K233991 |
12/18/2023 |
CanGaroo RM Antibacterial Envelope |
Elutia Inc. |
Erica Elchin |
| K234027 |
12/20/2023 |
embecta Insulin Delivery System |
Embecta Medical I, LLC |
Andrew Harrell |
| K230457 |
02/21/2023 |
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
Empatica S.r.l. |
Alberto Poli |
| K234085 |
12/22/2023 |
LUNEÖ PureHygiene |
Enamel Pure |
Nathan Monty |
| K233855 |
12/05/2023 |
AllPEP |
Enchant Tek Co. Ltd. |
Leonard Ling |
| K230441 |
02/21/2023 |
EMPOWR Stem Extender, 50mm |
Encore Medical, L.P DBA Enovis |
Thorsen Trey |
| K234108 |
12/27/2023 |
ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) |
Energy Resources International Co., Ltd. |
Pearl Tsai |
| K230358 |
02/10/2023 |
SAVI Dual (TM) Migraine Therapy |
eNeura, Inc. |
David Rosen |
| K230472 |
02/22/2023 |
Sonopuls 190 |
Enraf-Nonius, B.V. |
Thomas Jozef Doodkorte |
| K233920 |
12/13/2023 |
EOSedge |
EOS imaging |
Mathilde Masurel |
| K230343 |
02/08/2023 |
ProSealÖ Closed System Administration Set |
Epic Medical Pte Ltd |
Freddie Lee |
| K230387 |
02/14/2023 |
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S) |
Ethicon Endo-Surgery, LLC |
Ekta Patel |
| K234015 |
12/19/2023 |
Caphosol« Artifical Saliva (32 doses sachet box) |
EUSA Pharma (UK) Limited |
Sandy Suh |
| K230481 |
02/22/2023 |
Evenflo Premium Double Electric Breast Pump (Model 4018) |
Evenflo Feeding, Inc. |
Michael Sewak |
| K234042 |
12/21/2023 |
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K234097 |
12/26/2023 |
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Ever Growth (Vietnam) Corporation Limited |
Deng Elizabeth |
| K230468 |
02/21/2023 |
EzDent Web |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K230497 |
02/24/2023 |
Bladder AI (AIBV01) |
Exo Inc |
Jacqueline Murray |
| K234073 |
12/22/2023 |
ICE Aspiration System |
Expanse Medical Inc. |
Shiva Ardakani |
| K234058 |
12/22/2023 |
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K234053 |
12/22/2023 |
F&P Optiflow Flow Diverter |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K233821 |
12/01/2023 |
F&P Optiflow Oxygen Kit (AA451J) |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K233829 |
12/01/2023 |
Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); |
Fisher and Paykel Healthcare Limited |
Reena Daken |
| K233850 |
12/05/2023 |
Difiney Anti Snoring Device |
Fissiontech LLC |
Mike Lee |
| K234059 |
12/22/2023 |
Forma Medical Optimal Plating System |
Forma Medical, Inc. |
James Gault |
| K234061 |
12/22/2023 |
StarFormer |
Fotona d.o.o. |
Tina Bartolic |
| K233950 |
12/14/2023 |
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) |
Fresenius Medical Care Renal Therapies Group, LLC |
Timothy Groves |
| K230487 |
02/23/2023 |
Dental Lithium Disilicate Glass-Ceramic |
Fuzhou Rick Brown Biomaterials Co., Ltd. |
Zhong Huang |
| K230280 |
02/01/2023 |
ANDORATE« Suction Valve and ANDORATE« Biopsy Valve |
GA Health Company Limited |
Cindy Ye |
| K233884 |
12/08/2023 |
INUMIÖ Flex Needle |
Galvanize Therapeutics, Inc. |
Deborah Sheffield |
| K233839 |
12/04/2023 |
Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system |
GBS Commonwealth Co., Ltd. |
Sungji Yoon |
| K234130 |
12/28/2023 |
PortraitÖ Mobile Monitoring Solution consists of: ò PortraitÖ Central Viewer Application (Portrait CVAXB) ò PortraitÖ Core Services (Portrait CSSXB) ò PortraitÖ Clinical Alarming Unit (Portrait CAU01) ò PortraitÖ Mobile Patient Monitor Hardware (Port |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K230346 |
02/08/2023 |
Voluson SWIFT; Voluson SWIFT+ |
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC |
Bryan Behn |
| K234106 |
12/26/2023 |
Venue Fit |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Karin Shimoni |
| K234091 |
12/26/2023 |
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 |
Genalyte, Inc. |
Sasi Mudumba |
| K233885 |
12/08/2023 |
rainbow Paste Stain SE |
Genoss Co., Ltd. |
Hayoung Sung |
| K234023 |
12/20/2023 |
Oocyte Flushing & Retrieval Medium; Gamete Buffer |
Gimbo Medical Technology Shenzhen Co., Ltd. |
Leo Guo |
| K234035 |
12/20/2023 |
COSINEÖ Spacer |
Globus Medical, Inc. |
Jennifer Antonacci |
| K230397 |
02/14/2023 |
Cut Screw - Percutaneous Compression Screw |
GM Dos Reis Industria e Comercio Ltda |
Guilherme Esteves Pontes |
| K230325 |
02/06/2023 |
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System |
Greens Surgicals Pvt. Ltd. |
Vinay Kumar |
| K233979 |
12/18/2023 |
VACUETTE« QUICKSHIELD Complete (Plus) |
Greiner Bio-One North America Inc |
Manfred Abel |
| K230407 |
02/15/2023 |
FloNavi Open Field Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
Alice Lau |
| K230420 |
02/16/2023 |
Dr. pen Microneedling System |
Guangzhou Ekai Electronic Technology Co., Ltd. |
Guihua Chen |
| K233848 |
12/05/2023 |
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) |
Gynesonics, Inc |
Christine Ehmann |
| K230298 |
02/02/2023 |
Celsi Monitor |
Hadleigh Health Technologies |
Molly McCabe |
| K230461 |
02/21/2023 |
Quantra Hemostasis Analyzer |
HemoSonics, LLC |
Debbie Winegar |
| K234131 |
12/28/2023 |
Resolv Endoscopic Hemostat System |
Hemostasis LLC |
Lakshmi Ganesh Bollina |
| K234028 |
12/20/2023 |
COPAL« exchange G hip spacer; COPAL« G+V |
Heraeus Medical GmbH |
Heike Gustke |
| K230432 |
02/17/2023 |
Single Use Bipolar Forceps |
HG Innovations Ltd |
Dr.M Umran Rafiq |
| K230451 |
02/21/2023 |
Aptima« Chlamydia trachomatis Assay |
Hologic, Inc. |
Jon Kukowski |
| K234025 |
12/20/2023 |
22.2mm BIOLOX« delta Ceramic V40Ö Femoral Heads |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Meenakshi Verma |
| K230475 |
02/22/2023 |
Medical Video Endoscope System |
HUGER Medical Instrument Co., Ltd. |
Lei Lu |
| K230542 |
02/28/2023 |
Disposable Nitrile Gloves (ABC-DG01) |
Huizhou Anboson Technology Co., Ltd. |
Xuanli Weng |
| K230491 |
02/23/2023 |
HandXÖ Monopolar Scissors |
Human Xtensions Ltd. |
Hani Rauch |
| K230536 |
02/27/2023 |
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K233917 |
12/12/2023 |
ICHOR 7F Embolectomy System (ICH-7F) |
ICHOR |
Timothy Blair |
| K233842 |
12/04/2023 |
iHealth COVID-19 Antigen Rapid Test |
iHealth Labs, Inc |
Tianyang Liu |
| K230530 |
02/27/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K230531 |
02/27/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K233975 |
12/15/2023 |
Zoom 6F Insert Catheters |
Imperative Care, Inc. |
Nguyen Teri |
| K234044 |
12/21/2023 |
ACS« LD FB Knee System |
implantcast GmbH |
Juliane H÷ppner |
| K230313 |
02/06/2023 |
QUANTUM Patient Specific Instrumentation (PSI) System |
In2Bones SAS |
Sabina Ahaddad |
| K230494 |
02/23/2023 |
ClotTriever BOLD Catheter |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K230331 |
02/07/2023 |
Protrieve Sheath |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K234034 |
12/20/2023 |
VenaCore Thrombectomy Catheter (46-101) |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K233960 |
12/15/2023 |
INNOVERSE Spinal System |
Innosys Co., Ltd. |
Hye-Kyung Lee |
| K234119 |
12/28/2023 |
UniSpace« Stand-Alone C Cage |
Innosys Co., Ltd. |
Chae-Hyeon Kim |
| K233825 |
12/01/2023 |
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter |
Innovative Health |
Meerna Muradvich |
| K230376 |
02/13/2023 |
Reprocessed Agilis NxT Steerable Introducer |
Innovative Health, LLC. |
Rick Ferreira |
| K234049 |
12/21/2023 |
Straumann« BLC and TLC Implants - Line extension |
Institut Straumann AG |
Laure Kuhner Borsenberger |
| K230427 |
02/17/2023 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra Lifesciences Corporation |
Alexandra Wells |
| K230393 |
02/14/2023 |
UniCam Evo Software |
Inter Medical Medizintechnik GmbH |
Hans-Guenter Osiek |
| K230316 |
02/06/2023 |
FlexBand; FlexPatch; FlexBand Plus |
International Life Sciences |
Tiffini Wittwer |
| K230444 |
02/21/2023 |
Talee, Talee PostOp |
Invent Medical USA, LLC |
Jiri Rosicky |
| K230380 |
02/13/2023 |
Surgical Face Masks, Model: EFMDS-L50Pn BLU |
Iris USA |
Michael Cruz |
| K233995 |
12/18/2023 |
Ivotion Base Print |
Ivoclar Vivadent, Inc |
Anderjeet Gulati |
| K233881 |
12/08/2023 |
ivWatch« Model 400 |
ivWatch, LLC |
Holly Novak |
| K230517 |
02/27/2023 |
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) |
Jarmon Medical, LLC (DBA Legends Orthopedics) |
Jeremy Jarmon |
| K233896 |
12/11/2023 |
JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus |
JDentalCare Srl |
Antonio Grandi |
| K233912 |
12/12/2023 |
ARIX Cannulated Screw System |
Jeil Medical Corporation |
Jinwoo Kim |
| K230500 |
02/24/2023 |
Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) |
Jiangsu MaxF Electric Appliance Co., Ltd |
Zhang Jianfang |
| K230443 |
02/21/2023 |
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) |
Jiangxi Royall Smart Technology Co., Ltd. |
Shunzhou Yang |
| K233857 |
12/05/2023 |
Neodent Implant System û Custom Abutments |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Leticia Milani |
| K230359 |
02/10/2023 |
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle |
KARL STORZ Endoscopy America, Inc |
Michael Block |
| K230535 |
02/27/2023 |
KARL STORZ Urological Laser Accessories |
Karl Storz SE & CO. KG |
Alita McElroy |
| K233864 |
12/06/2023 |
ASSURE Wearable ECG |
Kestra Medical Technologies, Inc. |
Beverly Magrane |
| K230333 |
02/07/2023 |
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K230281 |
02/01/2023 |
PICOCLAMP |
Kono Seisakusho Co., Ltd |
Aya Takagi |
| K233868 |
12/06/2023 |
dima Print Teeth & Temp |
Kulzer, LLC |
David Vincent |
| K234107 |
12/26/2023 |
SolarÖ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) |
Laborie Medical Technologies Corp. |
Arpit Sisodiya |
| K234088 |
12/22/2023 |
Emily's Care Nourish Test System (Model 1) |
Lactation Lab Inc. |
Stephanie Canale |
| K230469 |
02/21/2023 |
Compact Wearable Pump |
Lansinoh Laboratories |
Lindsay Ewers |
| K230373 |
02/13/2023 |
HELIOS 785 Pico |
Laseroptek Co., Ltd. |
Hong Chu |
| K234039 |
12/21/2023 |
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) |
Lexington Medical, Inc. |
Sali Gully |
| K230336 |
02/07/2023 |
CurrentBody SkinÖ Led Hair Regrowth(Model: MZ-07) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K233962 |
12/15/2023 |
ReBorn (1050nm) |
LightFective Ltd. |
Tsvi Bahat |
| K234011 |
12/19/2023 |
AMF TT Cones |
LimaCorporate S.p.A |
Michela Zanotto |
| K230479 |
02/22/2023 |
ComASP Cefiderocol 0.008-128 |
Liofilchem s.r.l. |
Fabio Brocco |
| K230539 |
02/27/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K230499 |
02/24/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K230498 |
02/24/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K230339 |
02/07/2023 |
EsoCheck Cell Collection Device |
Lucid Diagnostics, Inc. |
Deepika Lakhani |
| DEN230083 |
12/14/2023 |
Valeda Light Delivery System |
LumiThera, Inc. |
Lori Holder |
| K233877 |
12/07/2023 |
XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) |
Magic Mobility |
Terence Walsh |
| K233953 |
12/15/2023 |
Makani ScienceÖ Respiration Monitoring System |
Makani Science, Inc. |
Michael Chu |
| K233879 |
12/08/2023 |
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) |
Maquet Cardiovascular, LLC |
Timothy Rice |
| K234021 |
12/20/2023 |
Masimo Stork |
Masimo Corporation |
Kertana Shankar |
| K230315 |
02/06/2023 |
Materialise Shoulder SystemÖ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner |
Materialise NV |
Giulia Girola |
| K230511 |
02/24/2023 |
K3900 Ultrasound Imaging System |
MAUI Imaging |
David Specht |
| K230529 |
02/27/2023 |
HealiAid Dental Collagen Wound Dressing |
Maxigen Biotech Inc. |
Cheng-Han Zhou |
| K230518 |
02/27/2023 |
HydraDose Vaginal Suppositories |
MD Labs LLC |
Harout Achekian |
| K234048 |
12/21/2023 |
M.U.S.T. Pedicle Screw System - Extension |
Medacta International S.A. |
Stefano Baj |
| K230544 |
02/28/2023 |
SnugFit All-Suture Anchor extension |
Medacta International S.A. |
Stefano Baj |
| K234062 |
12/22/2023 |
APTUS Hand Scaphoid Plates |
Medartis AG |
Claudia De Santis |
| K230398 |
02/16/2023 |
MedCAD« AccuPlate« 3DTi Patient-Specific Plating System |
MedCAD |
Brian Buss |
| K230528 |
02/27/2023 |
Extension Set |
Medcaptain Life Science Co., Ltd. |
Alan Tao |
| K234096 |
12/26/2023 |
MonoStereo |
MedicalTek Co., Ltd. |
Shen Ching (James) Yeh |
| K230465 |
02/21/2023 |
Hi-Bond Universal |
Mediclus Co., LTD. |
Hyeon-A Jo |
| K234113 |
12/27/2023 |
MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box |
Medimaging Integrated Solution, Inc. (MiiS) |
Sandy Chou |
| K234031 |
12/20/2023 |
Medline UNITE Ancillary Foot Recon Plating System |
Medline Industires, LP |
Jennifer Mason |
| K230559 |
02/28/2023 |
Hudson RCI« Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI« Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) |
Medline Industries, Inc. |
Nicole Schaffer |
| K234032 |
12/20/2023 |
Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/D |
Medline Industries, LP |
Phyllis Kondor |
| K234132 |
12/28/2023 |
Medline Reusable Sterilization Wrappers |
Medline Industries, LP |
Closen Kelsey |
| K234067 |
12/22/2023 |
ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) |
medPhoton GmbH |
Thomas Fessmann |
| K233830 |
12/01/2023 |
OsteoCoolÖ 2.0 RF Ablation System |
Medtronic Sofamor Danek USA Inc. |
Jeff Sprague |
| K233951 |
12/15/2023 |
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) |
Medtronic Sofamor Danek USA, Inc. |
Justin O'Connor |
| K230320 |
02/06/2023 |
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube |
Medtronic Xomed, Inc. |
Alexandra Oliver |
| K233838 |
12/04/2023 |
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); CovidienÖ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneo |
Medtronic, Inc |
Steve Pavlik |
| K233943 |
12/14/2023 |
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) |
Medtronic, Inc. |
Matthew Lobeck |
| K230553 |
02/28/2023 |
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application |
Medtronic, Inc. |
Kerry Luyster |
| K230301 |
02/03/2023 |
Athena III Cervical Plate System |
Medyssey USA, Inc. |
Youngsu Jang |
| K234142 |
12/29/2023 |
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment |
MegaGen Implant Co., Ltd. |
Hyo-Eun Lee |
| K233985 |
12/18/2023 |
TRIUXÖ neo (NM27000N ); MEGreview (SW26241N-B) |
Megin Oy |
Laura Vanonen |
| K230385 |
02/14/2023 |
Ballancer Platinum (1222) |
Mego Afek |
Yunger Reuven |
| K230495 |
02/23/2023 |
Serena Sleep Night Guard |
Meris Investment Group |
Gary Maas |
| K230418 |
02/16/2023 |
Mighty Wire Guide Wire |
Merit Medical Systems, Inc. |
James Kenny |
| K233926 |
12/13/2023 |
accufit |
Mettler Electronics Corporation |
An Le |
| K230364 |
02/10/2023 |
VitalFlowÖ Console |
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) |
Martha Rumford |
| K234147 |
12/29/2023 |
ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew |
Microline Surgical, Inc. |
Scott Marchand Davis |
| K234009 |
12/19/2023 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical |
Mark Wylie |
| K230473 |
02/22/2023 |
IPL Hair Removal Device Models: MLY-T069 |
Miley Technology(Hebei) Co., Ltd. |
Hualing Wang |
| K230501 |
02/24/2023 |
Spirobank Oxi |
MIR Medical International Research USA |
Dale Novy |
| K230369 |
02/10/2023 |
EUROPAÖ Navigated Instruments |
MiRus LLC |
Jordan Bauman |
| K234149 |
12/29/2023 |
MOLLI 2 System |
MOLLI Surgical, Inc. |
Joseph De Croos |
| K233822 |
12/01/2023 |
i2Contour |
MRIMath LLC |
Hassan Fathallah-Shaykh |
| K230548 |
02/28/2023 |
Myoaligner Appliance |
Myohealth Technologies, LLC |
Maryam Motlagh, DMD |
| K233970 |
12/15/2023 |
Nephron NitrileÖ, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) |
Nephron Nitrile, LLC. |
Lou Kennedy |
| K233924 |
12/13/2023 |
EMBOGUARD Balloon Guide Catheter |
Neuravi Limited |
Niall Fox |
| K234036 |
12/21/2023 |
SONIK MONARK 100 |
Neuro Spinal Innovation Inc |
Aslam Khan |
| K230314 |
02/06/2023 |
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K230514 |
02/24/2023 |
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series |
Nikkiso Co., Ltd. |
Satoko Hina |
| K230502 |
02/24/2023 |
Ear Pressure Relief Device(Model:ER813B) |
Ningbo Albert Novosino Co., Ltd. |
Victor Zhou |
| DEN230090 |
12/27/2023 |
First To Know Syphilis Test |
NOWDiagnostics |
Kevin Clark |
| K230463 |
02/21/2023 |
NSite Scoliosis Assessment App |
NSite, Inc. |
Michael J. Gardner |
| K234116 |
12/27/2023 |
Trigon Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies |
Analaura Villarreal Berain |
| K234050 |
12/21/2023 |
HALYARD« ONE-STEP« Sterilization Wrap, HALYARD« QUICK CHECK« Sterilization Wrap, HALYARD« SEQUENTIAL Sterilization Wrap and HALYARD« SMART-FOLD« Sterilization Wrap |
O&M Halyard, Inc. |
Anureet Singh |
| K230372 |
02/13/2023 |
VitreJect Syringe |
OcuJect, LLC |
Leonid Lerner |
| K233844 |
12/04/2023 |
OdneClean |
Odne AG |
Mark Bispinghoff |
| K234114 |
12/27/2023 |
CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) |
Okapi Medical LLC dba Resivant Medical |
Tom Stephens |
| K230552 |
02/28/2023 |
MR DWI/FLAIR Measurement V1.0 |
Olea Medical |
Nathalie Palumbo |
| K230424 |
02/17/2023 |
Omnia Medical Coupler-AÖ Anterior Lumbar Plate System; Omnia Medical Coupler-LÖ Lateral Lumbar Plate System |
Omnia Medical, LLC |
Troy Schifano |
| K233873 |
12/07/2023 |
XLO Brand of Locking Distal Humerus Plating System |
Ortho Life Systems Private Limited |
Tamandeep Kochhar |
| K233867 |
12/06/2023 |
Fitbone Trochanteric |
Orthofix Srl |
Elvira Taccarelli |
| K233910 |
12/12/2023 |
Vertex Hip Fracture Nailing System |
OrthoXel DAC |
Mark Moynihan |
| K230546 |
02/28/2023 |
SIGNEX |
OSTEONIC Co., Ltd. |
Hye-Min Ahn |
| K234095 |
12/26/2023 |
OtoNova/OtoNova Pro |
Otodynamics |
Daniel Budd |
| K233827 |
12/01/2023 |
OxiWear |
OxiWear, Inc. |
Shavini Fernando |
| K230474 |
02/22/2023 |
EVA5 Insufflator |
Palliare Ltd. |
John O'Dea |
| K230505 |
02/24/2023 |
OrthopantomographÖ OP 3D LX |
Palodex Group OY |
Frank Ray |
| K230550 |
02/28/2023 |
JAWS Nitinol Staple System |
Paragon 28 Inc |
Haylie Hertz |
| K234128 |
12/28/2023 |
Phantom Fibula Nail System |
Paragon 28, Inc. |
Haylie Fast |
| K234060 |
12/22/2023 |
KIDNEYvault Portable Renal Perfusion System |
Paragonix Technologies |
Lucas Churchill |
| K233935 |
12/14/2023 |
DigiLine Direct Print Aligner System |
Park Dental Research Corporation |
Logan Simmons |
| K233965 |
12/15/2023 |
UltraDrape UGPIV Barrier and Securement (34-15) |
Parker Laboratories, Inc. |
Candy Beck |
| K230483 |
02/23/2023 |
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) |
Passy-Muir, Inc. |
Donna Malter |
| K233942 |
12/14/2023 |
PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) |
Pentax of America, Inc. |
Gurvinder Singh Nanda |
| K230284 |
02/02/2023 |
Penumbra LP Coil System |
Penumbra, Inc. |
Samyukta Rangachari |
| K230294 |
02/02/2023 |
CoverScan (CoverScan v1.1) |
Perspectum |
Ioan Wigley |
| K233930 |
12/14/2023 |
MRCP+ version 2 (MRCP+ v2) |
Perspectum |
Keri Hildick |
| DEN230087 |
12/20/2023 |
AMStent« Tracheobronchial Covered Stent System |
Peytant Solutions, Inc. |
John Schorgl |
| K233945 |
12/14/2023 |
ProxiDiagnost N90 / Precision CRF (706110, 706400) |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K233853 |
12/05/2023 |
LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub |
Philips Medical Systems Nederland B.V. |
Jeanette Becker |
| K233899 |
12/11/2023 |
Knee+ |
Pixee Medical |
Lucie Pecheur |
| K230384 |
02/14/2023 |
PolyWear« Personal Protective Level 3 Gown |
Polyconversions, INC |
William Smith |
| K233992 |
12/18/2023 |
Precision AI Surgical Planning System (PAI-SPS) |
Precision AI Pty Ltd |
Sara Baniadam |
| K233862 |
12/06/2023 |
NUNA LUX (NUNL528) |
Premier North America Inc. |
Doris Dong |
| K234014 |
12/19/2023 |
Obsidian« NOW |
Prismatik Dentalcraft, Inc. |
Nina Chiang |
| K234124 |
12/28/2023 |
Single Use Hemoclips |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K230297 |
02/02/2023 |
PMT Expandable Cage (PMT EXP) |
Providence Medical Technology, Inc |
Edward Liou |
| K233948 |
12/14/2023 |
ProvisioÖ SLT IVUSÖ System |
Provisio Medical, Inc. |
Robert Ashley |
| K230305 |
02/03/2023 |
THE Graft Collagen |
Purgo Biologics Inc. |
Byungsun Kim |
| K230304 |
02/03/2023 |
Polyisoprene Surgical Gloves |
Puyang Linshi Medical Supplies Co., Ltd. |
Catherine Liu |
| K230322 |
02/06/2023 |
SelectFlex Neurovascular Access System Family |
Q'apel Medical, Inc. |
Kim Ky |
| K230312 |
02/03/2023 |
Iris AirShuttleÖ |
Qfix |
McKenzie Banasik |
| K233841 |
12/04/2023 |
HD80 Series Ultrasound Diagnostic System |
Qingdao Hisense Medical Equipment Co., Ltd |
Yalan Wu |
| K230349 |
02/09/2023 |
Lyra RSV+hMPV Assay |
Quidel Corporation |
Selena Liu |
| K230429 |
02/17/2023 |
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device |
Rapid Medical Ltd. |
Orit Yaniv |
| DEN230011 |
02/16/2023 |
OcuCool |
RecensMedical, Inc. |
Gun-Ho Kim |
| K234081 |
12/22/2023 |
RedDrop ONE (One) |
RedDrop Dx |
Kris Buchanan |
| K233925 |
12/13/2023 |
Relu Creator |
Relu BV |
Holger Willems |
| K234134 |
12/29/2023 |
AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System |
ResMed Pty Ltd (Registration Number: 3004604967) |
Shu-Ying Huang |
| K230476 |
02/22/2023 |
Oran Park Mask |
ResMed Pty Ltd (Registration Number: 3004604967) |
Daniellia Chan |
| K234087 |
12/22/2023 |
restor3d TIDAL Lumbar Interbody Fusion System |
restor3d |
Anika Moorjani |
| K234004 |
12/19/2023 |
Medical diode laser systems (CHARISMA, REGAL) |
Reveal Lasers Ltd. |
Mike Collette |
| K230455 |
02/21/2023 |
Enamel Coating Resin |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| DEN230012 |
02/16/2023 |
Ruthless Spine RJB |
Ruthless, LLC dba Ruthless Spine |
Renita Howard |
| K230292 |
02/02/2023 |
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification |
Samsung Electronics Co., Ltd |
Hon Pak |
| K233922 |
12/13/2023 |
SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG |
SATELEC-ACTEON GROUP |
Philippe Girard |
| K230408 |
02/15/2023 |
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K230486 |
02/23/2023 |
Cove Strip |
SeaSpine Orthopedics Corporation |
Cindy Toyama |
| K234099 |
12/26/2023 |
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant |
Select Labs, LLC |
Om Singh |
| K233990 |
12/18/2023 |
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) |
Shandong Xingyu Gloves Co., Ltd. |
Carrie Lee |
| K230447 |
02/21/2023 |
Sterile Syringe Bulk Tray |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Hualong Liu |
| K230342 |
02/08/2023 |
Phototherapy System (OL-PDT950) |
Shanghai Omni Laser Skinology Co., Ltd. |
Avril Ouyang |
| K234154 |
12/29/2023 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K233897 |
12/11/2023 |
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) |
Shenzhen Beacon Display Technology Co., Ltd. |
Li Yafei |
| K233901 |
12/11/2023 |
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) |
Shenzhen Desida Technology Co., Ltd. |
Shuangcheng Yuan |
| K233823 |
12/01/2023 |
Ultrasonic Fetal Doppler |
Shenzhen Jamr Technology Co., Ltd. |
Haiyu Zhang |
| K230409 |
02/15/2023 |
Wrist Type Blood Pressure Monitor (W05,W1101L) |
Shenzhen Jamr Technology Co., Ltd. |
Haiyu Zhang |
| K230360 |
02/10/2023 |
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 |
Shenzhen Jizhimei Technology Co., Ltd. |
Guo Miaosi |
| K230362 |
02/10/2023 |
Planar LED mate |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K233880 |
12/08/2023 |
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) |
Shenzhen Root Innovation Technology Co., Ltd. |
Athena Pan |
| K230351 |
02/09/2023 |
LED Facial Mask |
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd |
Ava Hu |
| K233887 |
12/08/2023 |
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 D |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Blue Fang |
| K230549 |
02/28/2023 |
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG |
Shenzhen Xiazhifeng Electronic Co., Ltd. |
James Li |
| K233914 |
12/12/2023 |
XVbeam2000 |
Shenzhen Xpectvision Technology Co., Ltd. |
Silver Cai |
| K233946 |
12/14/2023 |
IMMULITE« 2000 BR-MA |
Siemens Healthcare Diagnostics Products Ltd |
Karlyn Kellogg |
| K230561 |
02/28/2023 |
Syngo Carbon Space VA30A |
Siemens Healthcare GmBH |
Vijay Ramadas |
| K230421 |
02/16/2023 |
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K230402 |
02/15/2023 |
ENROUTE« Transcarotid Neuroprotection System |
Silk Road Medical |
Denise Aycox |
| K233949 |
12/14/2023 |
ACCORD Cable System |
Smith & Nephew, Inc. |
Anne Remington |
| K230555 |
02/28/2023 |
Cemented Tibia Baseplate no Taper with JRNY Lock |
Smith & Nephew, Inc. |
Madison Padgett |
| K233937 |
12/14/2023 |
OW100S |
Softwave/TRT LLC |
Cherita James |
| K233977 |
12/18/2023 |
Velacur |
Sonic Incytes |
Tinuade Orimalade |
| K230365 |
02/10/2023 |
Sonio Detect |
Sonio |
Florian Akpakpa |
| DEN230082 |
12/07/2023 |
Stone Clear (SC-LP9-01) |
SonoMotion, Inc. |
Oren Levy |
| K230538 |
02/27/2023 |
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid |
Sonova AG |
Nelson Hu |
| K234080 |
12/22/2023 |
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) |
Soterix Medical, Inc. |
Danielle Dadona |
| K230386 |
02/14/2023 |
SpassageQ |
Spass Inc. |
Yonghwan Kim |
| K234150 |
12/29/2023 |
Lucent« XP |
Spinal Elements |
Julie Lamothe |
| K230482 |
02/22/2023 |
SwedgeÖ Pedicle Screw Fixation System |
Spinal Resources, Inc. |
Bernie Bedor |
| K234051 |
12/21/2023 |
Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 |
Spinal Simplicity LLC |
Adam Rogers |
| K230445 |
02/21/2023 |
OnX Tough |
SprintRay Inc. |
Sara Moghtadernejad |
| K234140 |
12/29/2023 |
VIVA combo RF System (VIVA combo RF System) |
STARmed Co., Ltd. |
Honggeun Lee |
| K230310 |
02/03/2023 |
STAT Medical Device Lancing System |
STAT Medical Devices |
Hemel Mariano |
| DEN230085 |
12/18/2023 |
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator |
STERIS |
Anthony Piotrkowski |
| K230560 |
02/28/2023 |
enspire 300 Series Automated Endoscope Reprocessor System |
STERIS Corporation |
Gregory Land |
| K230558 |
02/28/2023 |
Revital-Ox PAA High Level Disinfectant Chemical Indicator |
STERIS Corporation |
Gregory Land |
| K230416 |
02/16/2023 |
Triathlon« Hinge Knee System; Triathlon« Revision Insert X3« |
Stryker |
Allison Byrne |
| K233893 |
12/08/2023 |
AlphaVent Knotless SP PEEK Anchor |
Stryker Endoscopy |
Madison Mutchler |
| K230512 |
02/24/2023 |
Gamma4 System |
Stryker GmbH |
Cindy Leon |
| K233919 |
12/13/2023 |
VariAx 2 Distal Radius System |
Stryker GmbH |
Ileana Freige |
| K230446 |
02/21/2023 |
TiLink-L SI Joint Fusion System |
Surgentec, LLC |
Andrew Shoup |
| K234064 |
12/22/2023 |
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) |
Surgical Instrument Service and Savings Inc. |
Stephanie Boyle Mays |
| K234090 |
12/22/2023 |
EXPLORER AIR« II (8001, 8002, 8003); EXPLORER AIR« Sterile Drape (8004) |
SurgVision GmbH |
Daniela Mahan |
| K230287 |
02/02/2023 |
SaviSafe Safety Device |
Suzhou Savicred Biotechnology Co., Ltd. |
Jiajun Zhu |
| K233900 |
12/11/2023 |
Nordica PV Cryo Mapping Catheter |
Synaptic Medical Corporation |
Jake Harandi |
| K233967 |
12/15/2023 |
DePuy Synthes MatrixSTERNUM Fixation System |
Synthes GmbH |
Georgina Mueller |
| K233994 |
12/18/2023 |
VOLTÖ Proximal Humerus 3.5 Plating System |
Synthes GmbH |
Brendan Daly |
| K234063 |
12/22/2023 |
T2Candida 1.1 Panel |
T2Biosystems, Inc. |
Rachel Gilbert |
| K234155 |
12/29/2023 |
Nimbl (model PD08-N1) |
Tactile Medical |
Vishal Agarwal |
| K230423 |
02/17/2023 |
Electronic Peak Flow Meter |
Taian Dalu Medical Instrument Co., Ltd. |
Wang Yuqin |
| K233956 |
12/15/2023 |
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Ming Hsiu Hsiao |
| K233963 |
12/15/2023 |
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Ming Hsiu Hsiao |
| K230419 |
02/16/2023 |
Sequel Tampon with Plastic Applicator |
Tampro Inc |
Greta Meyer |
| K230276 |
02/01/2023 |
TECHFIT DISRP« System |
TECHFIT Digital Surgery |
Angela Marφa Lema-PΘrez |
| K233874 |
12/07/2023 |
tmCMF Solution |
TechMah CMF |
Mohamed Mahfouz |
| K230394 |
02/14/2023 |
EUROSCREW NG; EUROSCREW TCP NG |
Teknimed |
Fabian Marcq |
| K230480 |
02/22/2023 |
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) |
Teleflex Medical |
Hope West |
| K233999 |
12/18/2023 |
GalaFLEX LITE Scaffold |
Tepha, Inc. |
Rajagopalan Prithi |
| K230412 |
02/15/2023 |
Symmed Elite Aesthetic |
TermoSalud |
Cristina Cifuentes Pantoja |
| K234065 |
12/22/2023 |
CDI OneView Monitoring System |
Terumo Cardiovascular Systems Corporation |
Rahul Reddy Chinkeri |
| K230293 |
02/02/2023 |
TheraFace Mask |
Therabody, Inc. |
CJ Frederick, III |
| K234068 |
12/22/2023 |
ART-Plan (v.2.2.0) |
Therapanacea SAS |
Bhairavi Ajachandra |
| K230311 |
02/03/2023 |
HyperSuture |
Threadstone L.L.C. |
Jeremy Clark |
| K234079 |
12/22/2023 |
HyperSuture Extension Line |
Threadstone L.L.C. |
Jeremy Clark |
| K230352 |
02/09/2023 |
Tornier Humeral Nail and Tornier Long Humeral Nail |
Tornier, Inc. |
Renato Juan |
| K230537 |
02/27/2023 |
Klassic Knee Revision System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K230526 |
02/27/2023 |
TEA Device |
Transtimulation Research, Inc. |
Jieyun Yin |
| K233863 |
12/06/2023 |
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Cal |
TriMed, INC |
David Anderson |
| K234040 |
12/21/2023 |
TriMed Threaded Intramedullary Nail System |
TriMed, INC |
David Medoff |
| K230545 |
02/28/2023 |
Inessa System |
Triple Jump Israel Ltd. |
Liron Hadar |
| K233858 |
12/05/2023 |
TriSalus TriGuideTM Guiding Catheter |
TriSalus Life Sciences |
Michael Aymami |
| K230438 |
02/21/2023 |
URIS Smart Path Implant System & Prosthetic |
TruAbutment Inc. |
Ki Yoon Nam |
| K233996 |
12/18/2023 |
Ulthera System (UC-1 Control Unit PRIME) |
Ulthera, Inc. |
Kim Kelly |
| K230557 |
02/28/2023 |
Eclipse Treatment Planning System (v18.0) |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K230326 |
02/06/2023 |
ENFit to ENFit Extension Sets |
Vesco Medical |
Chris O'Keefe |
| K230462 |
02/21/2023 |
OPTIX H2 Patient Specific Instrument System |
Vilex, LLC |
Brock Johnson |
| K234089 |
12/22/2023 |
DNA Appliance |
Vivos Therapeutics |
Kimberly Griffith |
| K230414 |
02/16/2023 |
ClariVyÖ Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K230471 |
02/21/2023 |
LinkSymphoKnee û Fixed Bearing Ultracongruent (FB UC) Articulating Surface |
Waldemar Link GmbH & Co. KG |
Pia Muller |
| K230488 |
02/23/2023 |
EL27-Compact; Sterile EHL-Probes |
Walz Elektronik GmbH |
Bernd Vollmer |
| K230439 |
02/21/2023 |
WellCare Anoscope |
Well Care (Wuhan) Medical Technology Co., Ltd |
Zhou Huimin |
| K233906 |
12/12/2023 |
S-Patch (S-Patch ExL) |
Wellysis Corp. |
Sam Engelman |
| K230464 |
02/21/2023 |
MixJect« Transfer Device |
West Pharma Services IL, Ltd. |
Llanit Goldgraber |
| K230527 |
02/27/2023 |
WishBone Medical Plate and Screw System |
WishBone Medical, Inc. |
Kayla Johnston |
| K234104 |
12/26/2023 |
PICOANDY (Q-Switched Nd:YAG Laser) |
Won Tech Co., Ltd. |
Hyunsik Yoon |
| K230274 |
02/01/2023 |
Medical Diode Laser (M2) |
Wuhan Pioon Technology Co.,Ltd. |
Feng Zhang |
| DEN230007 |
02/01/2023 |
LightStrike+ (MXSUV1-SL and MXSUV1-FT) |
Xenex Disinfection Services, Inc. |
Juan L. Gonzalez |
| K230506 |
02/24/2023 |
PureLift Pro Edition |
Xtreem Pulse |
Andrew Barile |
| K233859 |
12/06/2023 |
BASIS FLOW II |
Yamahachi Dental MFG., Co. |
Masashi Toyama |
| K234098 |
12/26/2023 |
Mobility Scooter (C4+) |
Yongkang Yile Vehicle Co., Ltd. |
David Shi |
| K233918 |
12/13/2023 |
Dental Barrier and Sleeves |
Yongqing Huaguan Dental Instruments Factory |
ZengYan Wu |
| K233903 |
12/11/2023 |
Zeta Cranial Navigation System (ZNS131-US) |
Zeta Surgical Inc |
Roman Stolyarov |
| K233958 |
12/15/2023 |
hekaDrill |
Zethon Ltd |
Faith Robertson |
| K233892 |
12/08/2023 |
3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) |
Zhuhai Dipu Medical Technology Co., Ltd. |
Huan Wang |
| K233840 |
12/04/2023 |
Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) |
Zhuhai Dipu Medical Technology Co., Ltd. |
Huan Wang |
| K234109 |
12/27/2023 |
Ziehm Solo FD |
Ziehm Imaging GmbH |
Tsvetelina Milanova |
| K230507 |
02/24/2023 |
Zimed Distal Medial Tibial Plate and Screw System |
Zimed Medikal |
H.Nurcan Bilgi |
| K230321 |
02/06/2023 |
PersonaÖ Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
