| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| 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 |
| K234118 |
12/28/2023 |
CentriMagÖ Acute Circulatory Support System |
Abbott Medical |
Bendre Ketaki |
| K234143 |
12/29/2023 |
i-STAT TBI Cartridge with the i-STAT Alinity System |
Abbott Point of Care |
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 |
| K233904 |
12/11/2023 |
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ |
Acist Medical Systems, Inc |
Bobbie Daughters |
| 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 |
| 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 |
| K234006 |
12/19/2023 |
AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test |
AllSource Screening Solutions |
Peter O'Connor |
| K234092 |
12/26/2023 |
SafeOp 3: Neural Informatix Systeem |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K233886 |
12/08/2023 |
Ambu« aScopeÖ Duodeno 2, Ambu« aBoxÖ 2 |
Ambu A/S |
Mette Andersen |
| 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 |
| 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 |
| 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 |
| 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 |
| K234005 |
12/19/2023 |
Access CK-MB |
Beckman Coulter, Inc |
Neha Desai |
| K234052 |
12/21/2023 |
Access Ferritin |
Beckman Coulter, Inc |
Kate Oelberg |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K233849 |
12/05/2023 |
BTL-499 |
BTL Industries, Inc. |
David Chmel |
| 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 |
| 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 |
| 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 |
| K234076 |
12/21/2023 |
iCare ALTIUS CW |
Centervue Spa |
Luca Scienza |
| 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 |
| 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 |
| K233908 |
12/12/2023 |
cNeuro cDAT |
Combinostics Oy |
Lennart Thurfjell |
| K234127 |
12/28/2023 |
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker |
CooperVision, Inc. |
Sahana Rajashekar |
| 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 |
| K233947 |
12/14/2023 |
KLIMTÖ Expandable Lumbar Interbody Fusion (LIF) Cage System |
CTL Medical Corporation |
Sean Suh |
| 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 |
| K233921 |
12/13/2023 |
Luvis Chair (LC700C) |
DENTIS CO., LTD. |
Kim Kaon |
| 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 |
| 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 |
| K233834 |
12/04/2023 |
Infinity Gateway Suite |
Draeger Medical Systems, Inc. |
Chris Riel |
| 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 |
| 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 |
| K234085 |
12/22/2023 |
LUNEÖ PureHygiene |
Enamel Pure |
Nathan Monty |
| K233855 |
12/05/2023 |
AllPEP |
Enchant Tek Co. Ltd. |
Leonard Ling |
| 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 |
| K233920 |
12/13/2023 |
EOSedge |
EOS imaging |
Mathilde Masurel |
| K234015 |
12/19/2023 |
Caphosol« Artifical Saliva (32 doses sachet box) |
EUSA Pharma (UK) Limited |
Sandy Suh |
| 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 |
| 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 |
| 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 |
| 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 |
| K233979 |
12/18/2023 |
VACUETTE« QUICKSHIELD Complete (Plus) |
Greiner Bio-One North America Inc |
Manfred Abel |
| K233848 |
12/05/2023 |
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) |
Gynesonics, Inc |
Christine Ehmann |
| 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 |
| K234025 |
12/20/2023 |
22.2mm BIOLOX« delta Ceramic V40Ö Femoral Heads |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Meenakshi Verma |
| 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 |
| 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 |
| 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 |
| K234049 |
12/21/2023 |
Straumann« BLC and TLC Implants - Line extension |
Institut Straumann AG |
Laure Kuhner Borsenberger |
| K233995 |
12/18/2023 |
Ivotion Base Print |
Ivoclar Vivadent, Inc |
Anderjeet Gulati |
| K233881 |
12/08/2023 |
ivWatch« Model 400 |
ivWatch, LLC |
Holly Novak |
| 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 |
| K233857 |
12/05/2023 |
Neodent Implant System û Custom Abutments |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Leticia Milani |
| K233864 |
12/06/2023 |
ASSURE Wearable ECG |
Kestra Medical Technologies, Inc. |
Beverly Magrane |
| 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 |
| 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 |
| K233962 |
12/15/2023 |
ReBorn (1050nm) |
LightFective Ltd. |
Tsvi Bahat |
| K234011 |
12/19/2023 |
AMF TT Cones |
LimaCorporate S.p.A |
Michela Zanotto |
| 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 |
| K234048 |
12/21/2023 |
M.U.S.T. Pedicle Screw System - Extension |
Medacta International S.A. |
Stefano Baj |
| K234062 |
12/22/2023 |
APTUS Hand Scaphoid Plates |
Medartis AG |
Claudia De Santis |
| K234096 |
12/26/2023 |
MonoStereo |
MedicalTek Co., Ltd. |
Shen Ching (James) Yeh |
| 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 |
| 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 |
| 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 |
| 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 |
| K233926 |
12/13/2023 |
accufit |
Mettler Electronics Corporation |
An Le |
| 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 |
| K234149 |
12/29/2023 |
MOLLI 2 System |
MOLLI Surgical, Inc. |
Joseph De Croos |
| K233822 |
12/01/2023 |
i2Contour |
MRIMath LLC |
Hassan Fathallah-Shaykh |
| 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 |
| DEN230090 |
12/27/2023 |
First To Know Syphilis Test |
NOWDiagnostics |
Kevin Clark |
| 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 |
| 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 |
| 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 |
| K234095 |
12/26/2023 |
OtoNova/OtoNova Pro |
Otodynamics |
Daniel Budd |
| K233827 |
12/01/2023 |
OxiWear |
OxiWear, Inc. |
Shavini Fernando |
| 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 |
| 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 |
| 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 |
| 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 |
| K233948 |
12/14/2023 |
ProvisioÖ SLT IVUSÖ System |
Provisio Medical, Inc. |
Robert Ashley |
| K233841 |
12/04/2023 |
HD80 Series Ultrasound Diagnostic System |
Qingdao Hisense Medical Equipment Co., Ltd |
Yalan Wu |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K233880 |
12/08/2023 |
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) |
Shenzhen Root Innovation Technology Co., Ltd. |
Athena Pan |
| 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 |
| 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 |
| K233949 |
12/14/2023 |
ACCORD Cable System |
Smith & Nephew, Inc. |
Anne Remington |
| K233937 |
12/14/2023 |
OW100S |
Softwave/TRT LLC |
Cherita James |
| K233977 |
12/18/2023 |
Velacur |
Sonic Incytes |
Tinuade Orimalade |
| DEN230082 |
12/07/2023 |
Stone Clear (SC-LP9-01) |
SonoMotion, Inc. |
Oren Levy |
| K234080 |
12/22/2023 |
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) |
Soterix Medical, Inc. |
Danielle Dadona |
| K234150 |
12/29/2023 |
Lucent« XP |
Spinal Elements |
Julie Lamothe |
| 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 |
| K234140 |
12/29/2023 |
VIVA combo RF System (VIVA combo RF System) |
STARmed Co., Ltd. |
Honggeun Lee |
| DEN230085 |
12/18/2023 |
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator |
STERIS |
Anthony Piotrkowski |
| K233893 |
12/08/2023 |
AlphaVent Knotless SP PEEK Anchor |
Stryker Endoscopy |
Madison Mutchler |
| K233919 |
12/13/2023 |
VariAx 2 Distal Radius System |
Stryker GmbH |
Ileana Freige |
| 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 |
| 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 |
| 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 |
| K233874 |
12/07/2023 |
tmCMF Solution |
TechMah CMF |
Mohamed Mahfouz |
| K233999 |
12/18/2023 |
GalaFLEX LITE Scaffold |
Tepha, Inc. |
Rajagopalan Prithi |
| K234065 |
12/22/2023 |
CDI OneView Monitoring System |
Terumo Cardiovascular Systems Corporation |
Rahul Reddy Chinkeri |
| K234068 |
12/22/2023 |
ART-Plan (v.2.2.0) |
Therapanacea SAS |
Bhairavi Ajachandra |
| K234079 |
12/22/2023 |
HyperSuture Extension Line |
Threadstone L.L.C. |
Jeremy Clark |
| 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 |
| K233858 |
12/05/2023 |
TriSalus TriGuideTM Guiding Catheter |
TriSalus Life Sciences |
Michael Aymami |
| K233996 |
12/18/2023 |
Ulthera System (UC-1 Control Unit PRIME) |
Ulthera, Inc. |
Kim Kelly |
| K234089 |
12/22/2023 |
DNA Appliance |
Vivos Therapeutics |
Kimberly Griffith |
| K233906 |
12/12/2023 |
S-Patch (S-Patch ExL) |
Wellysis Corp. |
Sam Engelman |
| K234104 |
12/26/2023 |
PICOANDY (Q-Switched Nd:YAG Laser) |
Won Tech Co., Ltd. |
Hyunsik Yoon |
| 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 |
