| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K230459 |
10/19/2023 |
C.C. Life 21 |
21 Equipment S.R.L. |
Dolores Moretto |
| K230777 |
10/06/2023 |
Patient Examination Gloves |
3A Glove Sdn. Bhd. |
Kumar Durarajen |
| K232775 |
10/10/2023 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
Jessica Stahle |
| K230285 |
10/27/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc |
Jacquelyn Gesumaria |
| K230300 |
10/27/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Brian Ma |
| K230275 |
10/27/2023 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Brian Ma |
| K231509 |
10/24/2023 |
Aco Apache Ultrasound System |
Aco Healthcare Co., Ltd. |
Henry Huang |
| K230478 |
10/19/2023 |
Acro Composites Interbody System |
Acro Composites, LLC |
Mitchell Bass |
| K213473 |
10/26/2023 |
Antimicrobial Gelling Fiber Dressing with PHMB |
Advanced Medical Solutions Ltd. |
Kay McGrath |
| K232751 |
10/30/2023 |
BriefCase-Triage |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K230854 |
10/27/2023 |
SwiftMR |
AIRS Medical Inc. |
Jihyeon Seo |
| K231238 |
10/31/2023 |
Ultravision2Ö System |
Alesi Surgical Ltd |
Michele Lucey |
| K231298 |
10/31/2023 |
Ultravision2Ö System Integrated Monopolar L-Hook (H/S)Ö |
Alesi Surgical Ltd. |
Dominic Griffiths |
| K231050 |
10/11/2023 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
| K232173 |
10/06/2023 |
Ascend VBR System, Ascend NanoTec VBR System |
Alphatec Spine, Inc. |
Sandy Gill |
| K232504 |
10/13/2023 |
Calibrate CCX Interbody System |
Alphatec Spine, Inc. |
Neha Mohindroo |
| K232044 |
10/06/2023 |
Invictus Robotic Navigation Instruments |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K231902 |
10/20/2023 |
GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAM |
Ansell Healthcare |
Carson Delaloye |
| K230104 |
10/16/2023 |
Anthogyr AXIOM« BL X3 implants, Anthogyr Multi-Unit components for AXIOM« BL |
Anthogyr |
Estelle Salle |
| K231960 |
10/03/2023 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
AnX Robotica Corporation |
Tim Thomas |
| K230370 |
10/13/2023 |
SpotLight/SpotLight Duo (with DLIR option) |
Arineta Ltd. |
Tanya Shalem |
| K232897 |
10/18/2023 |
Arthrex Small External Fixation System |
Arthrex Inc |
Jessica Kim |
| K232755 |
10/06/2023 |
Arthrex FiberTape and TigerTape Cerclage Sutures |
Arthrex Inc. |
Ruth Segall |
| K232211 |
10/24/2023 |
REUNION Sacroiliac Joint Fusion System |
Astura Medical |
Parker Kelch |
| K233170 |
10/26/2023 |
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) |
AtriCure, Inc. |
Erica Schwab |
| K230645 |
10/25/2023 |
BeneHoldÖ Surgical Incise Drape with CHG antimicrobial II |
Avery Dennison Medical Ltd. |
Lisa Bartakovics |
| K223905 |
10/06/2023 |
Vivio« LVEDP System |
Avicena, LLC |
Sean Brady |
| K231708 |
10/12/2023 |
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) |
AxoGen Corporation |
Shravani Shastry |
| K232070 |
10/11/2023 |
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K231567 |
10/04/2023 |
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K223697 |
10/13/2023 |
MRI compatibility for existing BioHorizons dental implants and abutments |
BioHorizons Implant Systems, Inc. |
Paul Leppo |
| K232201 |
10/23/2023 |
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 ╡g/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 ╡g/mL), VITEK 2 Streptococcus Penicillin |
bioMerieux, Inc |
Jared Bronson |
| K232395 |
10/05/2023 |
ETEST« Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ╡g/mL), ETEST« SUD |
bioMΘrieux |
Sophie Quiblier |
| K231340 |
10/30/2023 |
Renova Spine Balloon Catheter |
Biopsybell s.r.l. |
Carlo Ricca Prandi Bellini |
| K230755 |
10/30/2023 |
NuEra Tight RF Model OptiStream |
BIOS s.r.l. |
Martina De Iturbe |
| K231764 |
10/23/2023 |
Ultrasound System 1300 |
BK Medical Aps |
Bryan Behn |
| K233318 |
10/27/2023 |
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery Sys |
Boston Scientific Corporation |
Mr. Ian Broome |
| K233207 |
10/27/2023 |
Polaris XÖ Unidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Amy Reilly |
| K232844 |
10/04/2023 |
The IQoolTM System |
BrainCool AB |
Martin Waleij |
| K233185 |
10/24/2023 |
MODEL P8400 Controller for C2DXÆs Hemostatix Thermal Scalpel System |
C2DX, Inc. |
Brad Beale |
| K231300 |
10/06/2023 |
Nutricair Enteral Syringe with ENFit |
Cair LGL |
Irving L. Wiesen, Esq. |
| K232341 |
10/10/2023 |
CarboClear« Pedicle Screw System |
Carbofix Orthopedics Ltd. |
Hila Wachsler Avrahami |
| K232480 |
10/06/2023 |
ProtekDuo Veno-Venous Cannula Sets |
CardiacAssist, Inc. |
Mariah McMinn |
| K232051 |
10/24/2023 |
VISULAS green |
Carl Zeiss Meditec |
Tanesha Bland |
| K232091 |
10/22/2023 |
JO Coconut Hybrid Cooling Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K232090 |
10/11/2023 |
JO Coconut Hybrid Warming Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K230681 |
10/02/2023 |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl |
Central Medicare Sdn. Bhd. |
Chua Kah Ying |
| K222459 |
10/27/2023 |
Centrix FluoroSilver Silver Diamine Fluoride 38% |
Centrix Inc |
Greg Moreau |
| K231381 |
10/19/2023 |
Xpert Xpress MVP; GeneXpert Xpress System |
Cepheid |
Suzette Chance |
| K230440 |
10/13/2023 |
Xpert« Xpress CoV-2 plus |
Cepheid« |
Suzette Chance |
| K232704 |
10/05/2023 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K232429 |
10/13/2023 |
Titan Dental Design |
ClearAdvance, LLC |
Frank Puig |
| K230125 |
10/13/2023 |
Neuroblade System |
ClearMind Biomedical |
Vance Lin |
| K230814 |
10/31/2023 |
VRNT |
CognifiSense, Inc. |
Tassilo Baeuerle |
| K233101 |
10/26/2023 |
Luja Coude (20108 Male CH18 - large packaging) |
Coloplast Corp |
Troy Thome |
| K231732 |
10/23/2023 |
CleanSeal Advanced Bipolar Vessel Sealer Maryland |
Conmed Corporation |
Ali AbuSaleh |
| K230135 |
10/04/2023 |
Copioumed Chemotherapy Isolation Gown |
Copioumed International Inc. |
James Liu |
| K231494 |
10/27/2023 |
CoreLink Robotic Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K231934 |
10/27/2023 |
GIAÖ Stapler with Tri-StapleÖ Technology |
Covidien |
Leo Chen |
| K231395 |
10/18/2023 |
INNO SLA Submerged Narrow Implant System |
Cowellmedi Co., Ltd. |
Haejun Lee |
| K230328 |
10/31/2023 |
Speedboat Flush SB1 Instrument |
Creo Medical Ltd |
Diane Davis |
| K232809 |
10/12/2023 |
Cross Vascular RF Generator and Footswitch (optional accessory) |
Cross Vascular Inc. |
Jennifer Willner |
| K232852 |
10/12/2023 |
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable |
Cross Vascular Inc. |
Jennifer Willner |
| K232367 |
10/05/2023 |
cmAngio« V1.0 |
CureMetrix, Inc. |
Kevin Harris |
| K232924 |
10/18/2023 |
T-Line« Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K231001 |
10/05/2023 |
DeepTek CXR Analyzer v1.0 |
DeepTek Medical Imaging Pvt Ltd |
Carrillo Rory |
| K230144 |
10/06/2023 |
Denti.AI Detect |
Denti.AI Technology, Inc. |
Lyudmila Tuzova |
| K231578 |
10/20/2023 |
Lucitone Digital Print Denture System |
Dentsply Sirona |
Rebecca Sporer |
| K230199 |
10/18/2023 |
Byte Aligner System |
Dentsply Sirona Inc. |
Sobrin Laura |
| K233233 |
10/11/2023 |
EMPHASYS Femoral Stems |
DePuy Ireland UC |
Sarah Matamisa |
| K232448 |
10/12/2023 |
FREEPRINT« splintmaster |
Detax GmbH |
Markus Stratmann |
| K231214 |
10/27/2023 |
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT |
DiaSorin Inc. |
Kelly Olien |
| K230490 |
10/27/2023 |
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 |
| K232056 |
10/06/2023 |
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 |
Dongguan Lide Electric Appliance Co., Ltd |
Xiang Guojun |
| K231814 |
10/12/2023 |
ValvuloPro Valvuloplasty Balloon Catheter |
Dongguan TT Medical, Inc |
Yuying Bi |
| K230148 |
10/11/2023 |
Vlab |
DormoTech Medical Ltd. |
Abed Nassir |
| K231477 |
10/17/2023 |
Infinity CentralStation Wide, Infinity M300, Infinity M300+ |
Draeger Medical Systems, Inc. |
Deborah Herrington |
| K232722 |
10/03/2023 |
endo.digital Platform |
DreaMed Diabetes Ltd |
Eran Atlas |
| K231225 |
10/18/2023 |
EConsole1 |
DRTECH Corporation |
Kim Hanbyul |
| K230919 |
10/24/2023 |
Acumen IQ finger cuff |
Edwards Lifesciences, LLC |
Anna Hwang |
| K232294 |
10/31/2023 |
HemoSphere Alta Advanced Monitoring Platform; HemoSphere AltaÖ Advanced Monitor (Smart Recovery); HemoSphere AltaÖ Advanced Monitor (Cardiac); HemoSphere AltaÖ Advanced Monitor (All-on-One) |
Edwards Lifesciences, LLC |
Varad Raghuwanshi |
| K222222 |
10/12/2023 |
Artemis, Artemis TPO, Artemis MX |
Eigen |
William Mandel |
| K233090 |
10/27/2023 |
DEKA AGAIN PRO family |
El. En. S.p.A. |
Paolo Peruzzi |
| K230457 |
10/30/2023 |
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
Empatica S.r.l. |
Alberto Poli |
| K230893 |
10/23/2023 |
Swiss LthoClast Trilogy |
EMS Electro Medical Systems SA |
TimothΘe Deblock |
| K230472 |
10/24/2023 |
Sonopuls 190 |
Enraf-Nonius, B.V. |
Thomas Jozef Doodkorte |
| K232086 |
10/24/2023 |
spineEOS |
EOS imaging |
Mathilde Masurel |
| K231629 |
10/31/2023 |
091 Balloon Guide Catheter |
EOSolutions, Corp. |
Marc Litzenberg |
| K231025 |
10/04/2023 |
EFAI NeuroSuite CT ICH Assessment System |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K230717 |
10/12/2023 |
Exactech« Vantage« Total Ankle System |
Exactech, Inc. |
Pedro Ravelo |
| K232578 |
10/11/2023 |
VASSALLO GT 018 G12; VASSALLO GT 018 G30 |
Filmec Co. Ltd. |
Toshiya Osawa |
| K232574 |
10/11/2023 |
VASSALLO GT Crossing14 |
Filmec Co. Ltd. |
Toshiya Osawa |
| K232484 |
10/19/2023 |
KeyLiftÖ Expandable Interlaminar Stabilization System |
FloSpine |
Peter Harris |
| K232878 |
10/17/2023 |
TransLoc 3D |
Foundation Fusion Solutions, LLC (dba CornerLoc) |
Robert Compton |
| K231574 |
10/12/2023 |
Scenaria View 4.2 |
Fujifilm Healthcare Americas Corporation |
Chaitrali Kulkarni |
| K232118 |
10/16/2023 |
ANDORATE« Valve Kit |
GA Health Company Limited |
Cindy Ye |
| K232822 |
10/13/2023 |
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K220493 |
10/27/2023 |
Plaxpot Multi Plasma |
GCS Co. Limited |
Su Kyung Park |
| K232346 |
10/27/2023 |
Digital Expert Access with Remote Scanning |
GE Healthcare |
Allena Holzworth |
| K232344 |
10/11/2023 |
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR |
GE Medical Systems SCS |
Hubert Welsch |
| K231965 |
10/30/2023 |
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K222025 |
10/11/2023 |
G4Derm / G4Derm Plus Synthetic Wound Matrix |
Gel4Med, Inc. |
Ana Tellechea |
| K232318 |
10/31/2023 |
VICTORYÖ Lumbar Plate System |
Globus Medical, Inc |
Jennifer Antonacci |
| K231243 |
10/31/2023 |
Finger Clip Pulse Oximeter |
Guangdong Genial Technology Co., Ltd. |
Yu Jun |
| K231327 |
10/25/2023 |
POWERSEAL Sealer and Divider |
Gyrus ACMI, Inc. |
Dolan Mills |
| K233417 |
10/26/2023 |
AllTest Fentanyl Urine Test Cassette |
Hangzhou AllTest Biotech Co.,Ltd |
Rosa Wu |
| K231545 |
10/27/2023 |
hearOAE |
hearX SA (Pty) Ltd |
Seline Van Der Wat |
| K230897 |
10/11/2023 |
Anterion |
Heidelberg Engineering GmbH |
Arianna Schoess Vargas |
| K223557 |
10/20/2023 |
SPECTRALIS HRA+OCT and variants |
Heidelberg Engineering GmbH |
Arianna Schoess Vargas |
| K231642 |
10/13/2023 |
Veuron-Brain-pAb3 |
Heuron Co., Ltd. |
Lee Hae Ri |
| DEN220087 |
10/06/2023 |
Edison System |
HistoSonics, Inc. |
Daniel Kosednar |
| K232675 |
10/05/2023 |
Heating Tens, FT-615 |
Hivox Biotek Inc. |
Leslie Peng |
| K233241 |
10/27/2023 |
SOLACE Sacroiliac Fixation System |
HT Medical LLC dba Xenix Medical |
Teresa Cherry |
| K232356 |
10/24/2023 |
Laser Cap, Model: Hat-01 |
Hubei YJT Technology Co.,Ltd |
Jiali Xie |
| K231725 |
10/16/2023 |
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) |
Hunan Endoso Life Technology Co., Ltd. |
Fu Wang |
| K232143 |
10/23/2023 |
Applanation Tonometer HT-5000 |
Huvitz Co., Ltd. |
Heo Hyung-Min |
| K232760 |
10/06/2023 |
Swoop« Portable MR Imaging System« |
Hyperfine, Inc. |
Christine Kupchick |
| K230085 |
10/03/2023 |
Lung-CAD |
Imagen Technologies, Inc |
Rebecca Jones |
| K230249 |
10/16/2023 |
Ikshana |
ImmersiveTouch |
Prashant Banerjee |
| K232089 |
10/17/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K231413 |
10/10/2023 |
IPD Dental Implant Abutments |
Implant Protesis Dental 2004 S.L. |
Francesc Fumanal |
| K232371 |
10/19/2023 |
Actinia« hip stems |
implantcast, GmbH |
Juliane H÷ppner |
| K230842 |
10/25/2023 |
SignalHF (IM008) |
Implicity Inc. |
Caroline Florequin |
| K230265 |
10/06/2023 |
MoMe« ARC Wireless Ambulatory ECG Monitoring and Detection System |
InfoBionic, Inc. |
Dave MacCutcheon |
| K231495 |
10/13/2023 |
The Evolve System with the Transform Applicator |
InMode Ltd. |
Suhair Francis |
| K231737 |
10/26/2023 |
ANAXÖ 5.5 Spinal System |
Innosys Co., Ltd. |
Hye-Kyung Lee |
| K231899 |
10/17/2023 |
HAtetracellÖ-C Titanium Cervical IBF System |
Innovasis, Inc. |
Michael Thomas |
| K233292 |
10/27/2023 |
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress |
inomed Medizintechnik GmbH |
Tomasz Moszkowski |
| K231378 |
10/30/2023 |
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 |
Insightec, Ltd. |
Inbal Ben Tzvi |
| K231826 |
10/18/2023 |
Omnipod 5 ACE Pump |
Insulet Corporation |
Maria Brower |
| K231824 |
10/18/2023 |
SmartBolus Calculator |
Insulet Corporation |
Maria Brower |
| K232787 |
10/06/2023 |
ScanNav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Bhaskar Chikkanna |
| K223911 |
10/17/2023 |
Lumen 155-SF |
Intricon Corporation |
David Akbari |
| K232762 |
10/03/2023 |
dS Breast Coil 7ch 1.5T |
Invivo Corporation (Business Trade Name: Philips) |
Liselotte Kornmann |
| K232638 |
10/24/2023 |
FilteredFlo Warming Blankets |
IOB Medical Inc |
Jonathan Kovach |
| K230998 |
10/20/2023 |
Digital Wireless Intraoral X-Ray Sensor |
iRay Imaging Technology (Haining) Limited |
Junjie Qian |
| K231664 |
10/19/2023 |
IRRAflow Active Fluid Exchange System (AFES) |
IRRAS USA Inc. |
Jeanne S. Warner |
| K232436 |
10/25/2023 |
Rapid SDH |
iSchemaView, Inc. |
Jim Rosa |
| K232064 |
10/02/2023 |
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
Isikel Manufacturing LLC |
Chris Betts |
| K230130 |
10/10/2023 |
MicromateÖ Navi+ |
ISYS Medizintechnik GMBH |
Pedro Costa |
| K223740 |
10/05/2023 |
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) |
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. |
Heidi Zhang |
| K230741 |
10/13/2023 |
Macro & Micro-Test HCG Pregnancy Test Midstream |
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. |
Bella Xu |
| K230500 |
10/26/2023 |
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 |
| K213146 |
10/27/2023 |
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen |
Jiangsu Rongye Technology Co., Ltd. |
Tina Jiang |
| K232099 |
10/31/2023 |
Neodent Implant System - GM Zygomatic Implant System |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Mariana Soares Hartmann |
| K223541 |
10/27/2023 |
Cold/Hot Compression |
JKH Health Co., Ltd. |
Pu Jiang |
| K232586 |
10/24/2023 |
Rexious Spinal Fixation System, StateraÖ Spinal System, Statera-MÖ Spinal System |
K&J Consulting Corp. |
Jeena Mathai |
| K232406 |
10/03/2023 |
KARL STORZ OR1Ö SCB CONTROL (WU300) |
Karl Storz SE & Co. KG |
Thomas Ostrowski |
| K232359 |
10/02/2023 |
Surgical face mask |
Kingstar Medical (Xianning) Co., Ltd. |
Fan Rong |
| K230281 |
10/23/2023 |
PICOCLAMP |
Kono Seisakusho Co., Ltd |
Aya Takagi |
| K231704 |
10/19/2023 |
Pro-Link« & Pro-Link« Ti Barbs Cervical Spacer System |
Life Spine, Inc. |
Angela Batker |
| K232094 |
10/03/2023 |
Orchid Safety Release ValveTM |
Linear Health Sciences LLC |
Daniel Clark |
| DEN230002 |
10/04/2023 |
DuraGraft |
Marizyme, Inc. |
Navdeep Kaur Cheema |
| DEN200076 |
10/12/2023 |
ORi |
Masimo Corporation |
Linus Park |
| K230511 |
10/25/2023 |
K3900 Ultrasound Imaging System |
MAUI Imaging |
David Specht |
| K223126 |
10/11/2023 |
SurgiAid« Collagen Wound Dressing |
Maxigen Biotech, Inc. |
Cheng-Han Chou |
| K232767 |
10/04/2023 |
Nautilus VF ECMO Oxygenator |
MC3 Inc. |
Martha Rumford |
| K232123 |
10/18/2023 |
MectaLIF Anterior Lag Extension |
Medacta International S.A. |
Stefano Baj |
| K232280 |
10/29/2023 |
NextARÖ TSA Platform |
Medacta International S.A. |
Stefano Baj |
| K232042 |
10/20/2023 |
NexPortÖ Trocar System (TS211001); NexPortÖ Trocar System (TS211002); NexPortÖ Trocar System (TS211003); NexPortÖ Trocar System (TS211010); NexPortÖ Trocar System (TS211011); NexPortÖ Trocar System (TS211012); NexPortÖ Trocar System (TS221001); NexPortÖ T |
MediConcepts Technology (Shenzhen) Company Limited |
Nick Xu |
| K223926 |
10/06/2023 |
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box |
Medimaging Integrated Solution Inc. (MiiS) |
Jung-Yi Yen |
| K230602 |
10/31/2023 |
Hudson RCI« TurboMistÖ Nebulizer System |
Medline Industries LP |
Lakshmi Kanuri |
| K230559 |
10/26/2023 |
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 |
| K231907 |
10/18/2023 |
Medline Safety Insulin and TB Syringes |
Medline Industries, LP |
Kelsey Closen |
| K232905 |
10/19/2023 |
Medline UNITE« REFLEX« Nitinol Staple Kit |
Medline Industries, LP |
Jennifer Mason |
| K232492 |
10/06/2023 |
2.7 mm GRYPHONÖ Flex Knotless PEEK Anchor; 2.7 mm GRYPHONÖ Flex Knotless Biocomposite Anchor |
Medos International SARL |
Elizabeth P. Messana |
| K230083 |
10/31/2023 |
SAFIRA |
Medovate Limited |
Alan Finnerty |
| K231672 |
10/13/2023 |
S1 |
MedPark Co., Ltd. |
Woojong Kim |
| K232321 |
10/31/2023 |
FlexCath ContourÖ Steerable Sheath |
Medtronic Inc. |
Kripa Pandya |
| K231976 |
10/19/2023 |
StealthStation Cranial Software, v3.1.5 (9735585) |
Medtronic Navigation, Inc. |
Rishi Mehta |
| K232570 |
10/24/2023 |
SteerantÖ Super Stiff Guidewire |
Medtronic Vascular |
Amy Sanders |
| K230320 |
10/26/2023 |
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube |
Medtronic Xomed, Inc. |
Alexandra Oliver |
| K233320 |
10/31/2023 |
LINQ IIÖ Insertable Cardiac Monitor (LNQ22) |
Medtronic, Inc. |
Dustin Hawbaker |
| K223909 |
10/20/2023 |
R2GATE Lite TM |
MegaGen Implant Co. Ltd |
Tae Gyoun Lee |
| K230618 |
10/11/2023 |
MegaGen Dental Implant Systems Portfolio - MR Conditional |
MegaGen Implant Co., Ltd. |
Hyejin Jung |
| K230495 |
10/13/2023 |
Serena Sleep Night Guard |
Meris Investment Group |
Gary Maas |
| K230418 |
10/28/2023 |
Mighty Wire Guide Wire |
Merit Medical Systems, Inc. |
James Kenny |
| K223802 |
10/06/2023 |
accufit |
Mettler Electronics Corporation |
An Le |
| K232045 |
10/27/2023 |
MeVis Liver Suite |
MeVis Medical Solutions AG |
Rolf Rzodeczko |
| K231947 |
10/31/2023 |
EVOLUTION« Cement Keel |
MicroPort Orthopedics Inc. |
Jonas Susaraba |
| K232481 |
10/13/2023 |
RIGELÖ 3DR Anterior Cervical Corpectomy System |
MiRus, LLC |
Jordan Bauman |
| K232348 |
10/27/2023 |
RIGELÖ 3DR Standalone Anterior Cervical Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K231579 |
10/26/2023 |
MOLLI 2 |
MOLLI Surgical, Inc. |
Joseph De Croos |
| K232023 |
10/04/2023 |
Momentum Spine |
Momentum Health Inc. |
Evan Dimentberg |
| K211676 |
10/13/2023 |
Motiva Flora SmoothSilk Tissue Expander |
Motiva USA LLC |
Roslyn d'Incelli |
| K232922 |
10/20/2023 |
Pure-Vu EVS System |
Motus GI Medical Technologies Ltd. |
Mark Pomeranz |
| K230178 |
10/19/2023 |
EasyOne Sky Spirometer |
NDD Medizintechnik AG |
Andreas Senn |
| K223027 |
10/10/2023 |
NeuroTrigger Basic (NTB) |
NeuroTrigger |
Nikolai Kuincher |
| K230826 |
10/27/2023 |
Modius Sleep |
Neurovalens Ltd. |
Jason McKeown |
| K230220 |
10/11/2023 |
NeuViz 128 Multi-Slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Tian Yuehui |
| K221615 |
10/25/2023 |
Newclip Patient-matched instrumentation non sterile PSI |
Newclip Technics |
Gaelle Gourbiere |
| K233234 |
10/26/2023 |
PressON Spinal Fixation System |
Nexus Spine, LLC |
Jared Crocker |
| K231486 |
10/12/2023 |
Stable-L Standalone Lumbar Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K230853 |
10/06/2023 |
EARP Nerve Cuff Electrode |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K230209 |
10/20/2023 |
Sonix Health |
Ontact Health Co., Ltd. |
Hyuk-Jae Chang |
| K233093 |
10/25/2023 |
Balanced Knee« System TriMax PS Plus Tibial Insert |
Ortho Development Corporation |
Drew Weaver |
| K232998 |
10/12/2023 |
Montage- XT Settable, Resorbable Hemostatic Bone Putty |
Orthocon, Inc. |
Howard Schrayer |
| K231475 |
10/12/2023 |
MONTAGE-QS Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K230242 |
10/05/2023 |
OsteoCentric Dental Implant System |
OsteoCentric Technologies |
Todd Evans |
| K232276 |
10/06/2023 |
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ╡g) SUD20 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Amie Lovatt |
| K231231 |
10/12/2023 |
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices |
Paragon 28 Inc. |
Haylie Hertz |
| K232838 |
10/12/2023 |
Monkey RingsTM External Fixation System |
Paragon 28, Inc. |
Edward Wells-Spicer |
| K230284 |
10/25/2023 |
Penumbra LP Coil System |
Penumbra, Inc. |
Samyukta Rangachari |
| K232524 |
10/18/2023 |
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set |
Perfuze Ltd. |
Anne-Marie Gannon |
| K231539 |
10/21/2023 |
pRESET LITE Thrombectomy Device |
phenox Limited |
Rachel McDaid |
| K233348 |
10/24/2023 |
16 Breast Coil |
Philips Medical System Nederlands B.V. |
Shruti Sancheti |
| K232910 |
10/19/2023 |
CombiDiagnost R90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K232500 |
10/26/2023 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound |
Sudipta Chakrabarti |
| K230916 |
10/10/2023 |
WeSensor |
PICOPACK Inc. |
Dong-Il Kim |
| K232903 |
10/17/2023 |
Legend X Platform |
Pollogen Ltd |
Karen Smith |
| K232393 |
10/27/2023 |
BluTube« Dental Unit Water Purification Cartridge (BluTube«); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge |
ProEdge Dental Products, Inc. |
Mark Frampton |
| K230070 |
10/05/2023 |
MESORAM« Hypodermic Needle (710301); MESORAM« Hypodermic Needle (710302); MESORAM« Hypodermic Needle (712305); MESORAM« Hypodermic Needle (712315); MESORAM« Hypodermic Needle (710303); MESORAM« Hypodermic Needle (710307); MESORAM« Hypodermic Needle (71030 |
PromaMedical Inc. |
Christian Wehrenpfenning |
| K230091 |
10/06/2023 |
THE Cover |
Purgo Biologics Inc. |
Byungsun Kim |
| K230702 |
10/18/2023 |
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) |
Qingdao Kingon Medical Science and Technology Co., Ltd. |
Benrong Zhang |
| K232236 |
10/20/2023 |
Echo |
Quanta System Spa |
Dario Bandiera |
| K233091 |
10/26/2023 |
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) |
Qura S.r.l. |
Raffaella Tommasini |
| K231995 |
10/25/2023 |
AcuityUDR |
Radmedix LLC |
Gabriel Issa |
| K221550 |
10/05/2023 |
Evidence MultiSTAT DOA Urine MultiPlex |
Randox Laboratories Limited |
Karena Shaw |
| K220451 |
10/05/2023 |
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT |
Randox Laboratories Limited |
Karena Shaw |
| K232618 |
10/27/2023 |
Aurora Surgiscope System |
Rebound Therapeutics Corporation |
Timothy Connors |
| K230476 |
10/19/2023 |
Oran Park Mask |
ResMed Pty Ltd (Registration Number: 3004604967) |
Daniellia Chan |
| K233258 |
10/23/2023 |
Shadow Knotless All-Suture Anchors |
Responsive Arthroscopy LLC |
Garrett Ahlborg |
| K232763 |
10/04/2023 |
Electrode Handpieces (VCT, RFTV, BMDT series) |
RF Medical Co., Ltd |
Kwang S Choi |
| K231078 |
10/05/2023 |
All-Suture Anchor |
Riverpoint Medical, LLC |
Edwin Anderson |
| K232411 |
10/06/2023 |
JuggerKnot Soft Anchor OC |
Riverpoint Medical, LLC |
Becca DeFrancia |
| K233147 |
10/25/2023 |
PiXel8-RF |
Rohrer Aesthetics |
Mark Rohrer |
| K232407 |
10/06/2023 |
Cautery Protective Actuation System (CPAS) |
Safer Surgeries Medical Devices, LLC |
Rowland Grattan |
| K232561 |
10/23/2023 |
Ripley Spinal Screw System by SAGICO |
Sagico VA USA, Llc |
James Gibson, PhD, CPA |
| K231772 |
10/03/2023 |
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K233220 |
10/27/2023 |
EnCor EnspireÖBreast Biopsy System (E4115, E4230); EnCorÖ Breast Biopsy Driver (DRENCOR); EnCorÖ MRI Breast Biopsy Driver (DRENCORMR); EnCorÖ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCorÖ MRI Breast Biop |
SenoRx, Inc. |
Kathryn Swanstrom |
| K231105 |
10/17/2023 |
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) |
Shanghai AnQing Medical Instrument Co., Ltd |
Shuwen Fan |
| K231868 |
10/31/2023 |
Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 |
Shanghai BangBang Robotics Co., Ltd. |
Liu Canfeng |
| K232055 |
10/06/2023 |
Vial Adapter |
Shanghai Ling Fu Technology Co., Ltd. |
Esther Zhang |
| K230961 |
10/10/2023 |
Zeus Spinal System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K232712 |
10/03/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K232550 |
10/20/2023 |
Nitrile Examination Gloves, Dual Color Black-Blue |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Zhigang Wu |
| K232223 |
10/24/2023 |
PlaDuo System |
ShenB Co Ltd |
Sunny Kang |
| K232128 |
10/14/2023 |
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K231595 |
10/26/2023 |
Electric Breast Pump |
Shenzhen Changkun Technology Co., Ltd. |
Wang Qingpeng |
| K231310 |
10/27/2023 |
Electronic Blood Pressure Monitor |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Danyin Li |
| K232499 |
10/11/2023 |
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) |
Shenzhen Lescolton Electrical Appliance Co., Ltd. |
Chen Zhikui |
| K232460 |
10/11/2023 |
Disposable electrosurgical pencil (MD1000) |
Shenzhen Mecun Medical Supply Co., Ltd. |
Bo Zheng |
| K231685 |
10/26/2023 |
TE Air Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Zhang Yuxi |
| K231749 |
10/19/2023 |
Radio Frequency System |
Shenzhenshi Sincoheren S&T Development Co., Ltd. |
Cai Jialong |
| K231165 |
10/27/2023 |
Shina Syringe; Shina Safety Syringe |
Shina Med Corporation |
Tae Joo Ha |
| K232305 |
10/23/2023 |
AI-Rad Companion Brain MR |
Siemens Medical Solutions U.S.A. |
Kira Morales |
| K233270 |
10/28/2023 |
AcuNav Crystal Ultrasound Catheter |
Siemens Medical Solutions USA, Inc. |
Bongsoo Cho |
| K232145 |
10/30/2023 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K231560 |
10/23/2023 |
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K232271 |
10/26/2023 |
SIMDA abutment |
Simda Co., Ltd. |
Cha Young Woo |
| K231761 |
10/27/2023 |
PodSKAN HF Diagnostic X-ray System |
Skanray Technologies Limited |
Vasundhara R |
| K230707 |
10/12/2023 |
Skypro, Surgical Gown 6021 |
Skypro Medical Supplies Company |
Cyrus Wong |
| K232667 |
10/27/2023 |
OR3O Dual Mobility Liners |
Smith & Nephew, Inc. |
Madison Padgett |
| K231550 |
10/26/2023 |
Sontro« OTC Hearing Aids (AI) |
Soundwave Hearing, LLC |
Anthony Florek |
| K231551 |
10/12/2023 |
Stethophone |
Sparrow Acoustics Inc. |
Nadia Ivanova |
| K231069 |
10/25/2023 |
PERLA« TL Posterior Thoraco-lumbar Fixation System |
Spineart SA |
Franck Pennesi |
| K231781 |
10/18/2023 |
OptiMesh Multiplanar Expandable Interbody Fusion System |
Spineology Inc. |
Andrew Adams |
| K231658 |
10/10/2023 |
VEOS Spinal Fixation System |
Spineway |
Maurad Ben Mokhtar |
| K231603 |
10/06/2023 |
Standard Staple-Line Reinforcement (SSLR23) |
Standard Bariatrics, Inc. |
Trevor Barton |
| K233113 |
10/25/2023 |
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) |
STARmed Co., Ltd. |
Honggeun Lee |
| K222997 |
10/25/2023 |
VVR Generator system |
Starmed Co., Ltd. |
Honggeun Lee |
| K232951 |
10/20/2023 |
BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield |
Steris |
Carroll Martin |
| K233187 |
10/27/2023 |
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) |
Steris |
Anthony Piotrkowski |
| K233065 |
10/20/2023 |
V-PRO maX 2 Low Temperature Sterilization System |
Steris |
Jennifer Nalepka |
| K232918 |
10/03/2023 |
enspire 300 Series Automated Endoscope Reprocessor |
Steris Corporation |
Nalepka Jennifer |
| K232914 |
10/03/2023 |
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) |
STERIS Corporation |
Jennifer Nalepka |
| K232683 |
10/24/2023 |
Knotilus+ PEEK Knotless Anchor |
Stryker Endoscopy |
Madison Mutchler |
| K231908 |
10/27/2023 |
45 Micron Polyisoprene Condom |
Suretex Limited |
Alison Arnot |
| K232279 |
10/05/2023 |
LifeStyles NRL Textured Condom |
Suretex Limited |
Alison Arnot |
| K231716 |
10/02/2023 |
OsteoFlo« HydroPuttyÖ |
SurGenTec, LLC |
Travis Greenhalgh |
| K222143 |
10/13/2023 |
APIS (R), VERIS (TM) |
SweetBio, Inc |
Kayla Graff |
| K232981 |
10/11/2023 |
Synq Software Version 1.3 |
Synaptive Medical Inc. |
Ahmed Hamed |
| K232151 |
10/17/2023 |
Dynamic TiBase |
Talladium Espa±a, SL |
Xavier Soca Filella |
| K233044 |
10/05/2023 |
Tandem Mobi insulin pump with interoperable technology |
Tandem Diabetes Care Inc. |
Louise Focht |
| K231520 |
10/02/2023 |
tmCMF Solution |
TechMah CMF |
Mohamed Mahfouz |
| K223863 |
10/13/2023 |
BONHAWA Respiratory Humidifier |
Telesair, Inc. |
Yong (Bryan) Liu |
| K230983 |
10/20/2023 |
Unicare (K-UNICARE-USA) |
TensCare Ltd |
Saskia Eldridge-Hinmers |
| K230951 |
10/18/2023 |
Terumo Injection Filter Needle (NF-3013RBKE05M) |
Terumo Europe N.V. |
Liesbeth Decoster |
| K232235 |
10/25/2023 |
Magstim«Horizon« 3.0 TMS Therapy System; Horizon« 3.0 System; Horizon« 3.0; Horizon« 3.0 with Navigation; Horizon« 3.0 with StimGuide Pro |
The Magstim Company Ltd. |
Daniel Gregory |
| K232310 |
10/31/2023 |
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K222214 |
10/17/2023 |
ViVi« Surgical Helmet System (ViVi« Helmet, ViVi« Helmet HPL, ViVi« Hood) |
THI Total Healthcare Innovation GmbH |
Karl Hintermann |
| K232802 |
10/12/2023 |
TMINIÖ Miniature Robotic System |
Think Surgical, Inc. |
Anand Patel |
| K232020 |
10/16/2023 |
Iontophoresis Electrodes |
TOP-RANK Health Care Co., Ltd. |
Yao Feijie |
| K231222 |
10/30/2023 |
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) |
Topcon Corporation |
Ryota Kitawaki |
| K230352 |
10/31/2023 |
Tornier Humeral Nail and Tornier Long Humeral Nail |
Tornier, Inc. |
Renato Juan |
| K231362 |
10/31/2023 |
OCS Heart Leukocyte Depleting Filter |
TransMedics, Inc. |
Miriam Provost |
| K231874 |
10/30/2023 |
AOT & T-L Abutment |
TruAbutment Inc. |
Ki Yoon Nam |
| K232552 |
10/20/2023 |
TuxDeluxe (Size 1 6100B, Size 2 6101B) |
Tuxedo Imaging LLC |
Patrick Williams |
| K231809 |
10/20/2023 |
Momentum« Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum« MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement |
Ulrich Medical USA |
Eric Lucas |
| K221315 |
10/25/2023 |
UNIdental Symphony Implant System |
UNIdental Co., Ltd. |
Nam Kyu Kang |
| K231863 |
10/06/2023 |
ProBeam 360░ Proton Therapy System v2.0 (Multiroom) |
Varian Medical Systems, Inc. |
Peter Coronado |
| K232584 |
10/24/2023 |
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter |
Vein 360 LLC |
Suzanne Meyer |
| K231388 |
10/20/2023 |
NextDent Base |
Vertex-Dental B.V. |
Connie Peterse-van der Koppel |
| K232205 |
10/23/2023 |
Vesco QÖ Enteral Feeding Pump; Vesco QÖ 500mL Bag Feed Set; Vesco QÖ 1000mL Bag Feed Set; Vesco QÖ 40mm Screw Cap Feed Set; Vesco QÖ ENPlus Feed Set |
Vesco Medical, LLC |
Chris O'Keefe |
| K230650 |
10/12/2023 |
Monopolar Electrode Surgical Instrument |
VHMED (Nantong) Co. Ltd. |
Guan Yunjuan |
| K231398 |
10/04/2023 |
VUNO Med-DeepBrain |
VUNO Inc. |
Jiwon Song |
| K231836 |
10/30/2023 |
ClariVyÖ Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K232471 |
10/10/2023 |
Vy SpineÖ VyLamÖ Laminoplasty System |
Vy Spine, LLC |
Jordan Hendrickson |
| K231744 |
10/13/2023 |
VyLinkÖ Spinal Screw System |
Vy Spine, LLC |
Jordan Hendrickson |
| K232437 |
10/13/2023 |
Paragon 8F Balloon Guide Catheter |
Wallaby Medical |
Joseph Tang |
| K221972 |
10/02/2023 |
Warantec Custom Abutment |
Warantec Co., Ltd, |
Younggwang Choi |
| K221777 |
10/06/2023 |
Disposable Sterile Syringe |
Weihai Shengjie Medical Technology Co., Ltd |
Huihui Wang |
| K230570 |
10/16/2023 |
Willow Generation 3 Breast Pump |
Willow Innovations, Inc. |
Shruti Jayakumar |
| K231152 |
10/12/2023 |
Collagen Wound Dressing |
Winner Medical Co., Ltd. |
Yi Fu |
| K233223 |
10/26/2023 |
OGmend« Implant Enhancement System |
Woven Orthopedic Technologies |
Brandon Bendes |
| K232046 |
10/06/2023 |
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection |
Xeridiem Medical Devices, A Spectrum Plastics Group Company |
Steve Murray |
| K233210 |
10/25/2023 |
sam CS Long Duration Ultrasound Device |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K232230 |
10/03/2023 |
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
| K230662 |
10/26/2023 |
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs |
Zhonghong Pulin Medical Products Co.,Ltd. |
Li Yunjiao |
| K231029 |
10/30/2023 |
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl |
Zhonghong Pulin Medical Products Co.,Ltd. |
Li Yunjiao |
| K230780 |
10/05/2023 |
MFG-05 |
Zimmer MedizinSysteme GmbH |
Ute Killet |
| K230116 |
10/11/2023 |
VitalÖ Spinal Fixation System |
ZimVie Spine (Zimmer Biomet Spine, Inc.) |
Hanna Aucoin |
