| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K220560 |
07/14/2022 |
Dermatac Drape |
3M |
Melanie Avila |
| K220660 |
07/01/2022 |
Prevena Restor Adapti-Form Dressing |
3M Health Care Business Group |
Teri Feeley |
| K212778 |
07/15/2022 |
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) |
Abbott Molecular, Inc. |
Gina Sammarco |
| K221037 |
07/20/2022 |
TruDi Shaver Blade |
Acclarent, Inc. |
Leena Zalavadia |
| K221535 |
07/22/2022 |
Align Lumbar Interbody Fusion System |
Acuity Surgical Devices, LLC |
Bryan Cowan |
| K220784 |
07/01/2022 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Sindhu Sridhar |
| K220622 |
07/15/2022 |
Hailie Sensor NF0106 |
Adherium (NZ) Ltd |
Geoff Feakes |
| K212775 |
07/08/2022 |
Adin Short Implants |
Adin Dental Implants Systems Ltd. |
Iris Yadin-Herling |
| K221901 |
07/29/2022 |
EleGARD |
AdvancedCPR Solutions LLC |
Philip Faris |
| K221907 |
07/29/2022 |
RhinAer« Stylus (FG1393) |
Aerin Medical Inc. |
Shannon Scott |
| K213871 |
07/01/2022 |
Ennovate Cervical Spinal and Occiput System |
Aesculap Implant Systems, LLC. |
Paul Amudala |
| K203013 |
07/14/2022 |
AGNES |
Agnes Medical CO., LTD |
Chul Lee |
| K220039 |
07/20/2022 |
AutoSeg |
AI Medic Inc. |
Jeong Soon Song |
| K220624 |
07/22/2022 |
AI4CMR v1.0 |
AI4MedImaging Medical Solutions S.A. |
Carla Almeida |
| K212073 |
07/14/2022 |
Alma Diode Tabletop Laser |
Alma Lasers, Ltd. |
Avi Hirshnzon |
| K220606 |
07/25/2022 |
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 |
Ambu A/S |
Gurpreet Kaur Rehal |
| K220825 |
07/08/2022 |
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves |
American Nitrile Operations LLC |
Stephen Perrin |
| K221108 |
07/12/2022 |
Nitrile Medical Examination Gloves |
Anhui Fulewei Electronic Technology Co.,Ltd |
Beina Gong |
| K220204 |
07/14/2022 |
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K220876 |
07/27/2022 |
AOK 95A Medical Mask (20200049) |
AOK Tooling Limited |
Francis Nithyananthan |
| DEN210045 |
07/12/2022 |
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System |
Apollo Endosurgery, Inc. |
David M. Hooper |
| K220970 |
07/15/2022 |
Renuvion APR Handpiece |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
Priscilla Herpai |
| K213232 |
07/01/2022 |
NovaCore Semi-Automatic Biopsy Instrument |
Argon Medical Devices |
Daniel Lanois |
| K213315 |
07/01/2022 |
CROSSLEAD Peripheral Guide Wire |
Asahi Intecc Co., LTD. |
Tomoya Eguchi |
| K221399 |
07/08/2022 |
ZIPÖ MIS Interspinous Fusion System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K213104 |
07/29/2022 |
Auxilock Titanium Screw-In Suture Anchor |
Auxein Medical Private Limited |
Rahul Luthra |
| K220258 |
07/14/2022 |
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) |
AVIA Vascular |
Kevin Cook |
| K211952 |
07/21/2022 |
BTI Interna Narrow/Plus Dental Implant System UnicCa |
B.T.I. Biotechnology Institute, SL |
Jose Ramon Rivero |
| K213435 |
07/19/2022 |
MAGIC Flow-Dependent Microcatheter |
Balt USA, LLC |
Ryan Kenney |
| K211399 |
07/22/2022 |
Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown |
Barco Tekstil Sanayi ve Ticaret A.S. |
Emre Gomruk |
| K213955 |
07/16/2022 |
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub |
Becton, Dickinson and Company |
Samhitha Mohan |
| K214122 |
07/28/2022 |
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K211085 |
07/01/2022 |
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle |
Becton, Dickinson and Company |
Shan Lu |
| K213158 |
07/21/2022 |
Syringe with permanently attached needle |
Berpu Medical Technology Co., Ltd. |
David Yu |
| K221269 |
07/27/2022 |
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K210665 |
07/15/2022 |
Nerve Tape |
BioCircuit Technologies, Incorporated |
Jack Griffis |
| K221036 |
07/01/2022 |
Astroglide Warming |
BioFilm Inc. |
Kevin Jamil |
| K221460 |
07/25/2022 |
BioFire COVID-19 Test 2 |
BioFire Defense, LLC |
Cynthia Phillips |
| K213899 |
07/12/2022 |
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin |
bioMerieux, Inc. |
Esther Hernandez |
| K210793 |
07/08/2022 |
VIDAS NEPHROCHECK |
bioMΘrieux SA |
Julien Thao My |
| K213997 |
07/15/2022 |
Kontact Dental Implant System |
Biotech Dental, SAS |
Delphine Mercier |
| K222017 |
07/28/2022 |
Biotres |
Biotricity |
Spencer LaDow |
| K221856 |
07/27/2022 |
BIOMONITOR IIIm, BIOMONITOR III |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K214038 |
07/06/2022 |
Oscar Peripheral Multifunctional Catheter system |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K222037 |
07/19/2022 |
Selectra Lead Implantation System |
Biotronik, Inc. |
Jon Brumbaugh |
| K202852 |
07/29/2022 |
DiviTum TKa |
Biovica International AB |
Joakim Arwidson |
| K220958 |
07/27/2022 |
Real Intelligence Cori |
Blue Belt Technologies, Inc. |
Unnati Bhuptani |
| K211585 |
07/29/2022 |
Bodyport Cardiac Scale |
Bodyport Inc. |
Mara Korsunsky |
| K222014 |
07/28/2022 |
EXALT Model B Single-Use Bronchoscope |
Boston Scientific Corporation |
Carter Navarro |
| K213773 |
07/21/2022 |
Insufflation Retention Device |
Bpendo, LLC |
Robert Holbrook |
| K212215 |
07/19/2022 |
Tiche PTA Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
Crystal Lee |
| K221876 |
07/15/2022 |
Digital Radiography CXDI-Pro, Digital Radiography D1 |
Canon Inc. |
Akira Hirai |
| K211346 |
07/22/2022 |
BLUE 400 |
Carl Zeiss Meditec AG |
Hans-Joachim Miesner |
| K213007 |
07/06/2022 |
Cerebra Sleep System |
Cerebra Medical Ltd. |
Sharon Cholowsky |
| K220298 |
07/01/2022 |
CerroZone Mobile |
CerroZone |
Marlon E. Robinson |
| K221051 |
07/08/2022 |
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Changsha Honchon Technology Co., LTD |
Ling Li |
| K220024 |
07/06/2022 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
Kim Finch |
| K221431 |
07/14/2022 |
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant |
Church & Dwight Co., Inc. |
Supreet Sahota-Bhatti |
| K221823 |
07/21/2022 |
Cionic Neural Sleeve NS-100 |
CIONIC |
Mihai Ionescu |
| K213998 |
07/28/2022 |
cvi42 Auto Imaging Software Application |
Circle Cardiovascular Imaging Inc |
Sydney Toutant |
| K220922 |
07/27/2022 |
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
Cochlear Americas |
Samata Veluvolu |
| K221404 |
07/26/2022 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Mary Kruitwagen |
| K221945 |
07/28/2022 |
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER I |
Conmed Corporation |
Kavita Amin |
| K221914 |
07/29/2022 |
Catapult Guide Sheath |
Contract Medical International GmbH |
Juliana Vaz Nuernberger |
| K221464 |
07/27/2022 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K213911 |
07/29/2022 |
Microstream CO2 NanoPod |
Covidien LLC |
Andrew Berkeland |
| K221407 |
07/13/2022 |
truSculpt iD |
Cutera Inc. |
Amogh Kothare |
| K212509 |
07/18/2022 |
OSSIX Breeze |
Datum Dental Ltd. |
Arie Goldlust |
| K221429 |
07/14/2022 |
KDF Zirconia Disc |
DENKEN-HIGHDENTAL Co., Ltd. |
Daijiro Goto |
| K220216 |
07/22/2022 |
C-Stem AMT LE Prosthesis |
DePuy Ireland UC |
Sarah Matamisa |
| K221259 |
07/29/2022 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Rachel Ellena |
| K213858 |
07/26/2022 |
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus |
DiaSorin Inc. |
Christa Blaisdell |
| K213936 |
07/14/2022 |
LIAISON MeMed BV, LIAISON MeMed BV Control Set |
DiaSorin Inc. |
John C. Walter |
| K213252 |
07/27/2022 |
Dornier Thulio |
DornierMedTech America, Inc |
John Hoffer |
| K220956 |
07/20/2022 |
Libby Echo:Prio |
Dyad Medical, Inc |
Ronny Shalev |
| K221028 |
07/06/2022 |
SURGIVISIO Device |
Ecential Robotics |
Sarah Lefevre-Billard |
| K220943 |
07/19/2022 |
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim |
ECO Medi Glove Sdn.Bhd. |
Suresh Kumar |
| K220538 |
07/11/2022 |
DolorClast Radial |
EMS Electro Medical Systems SA |
TimothΘe Deblock |
| K213387 |
07/07/2022 |
AltiVate« Anatomic Shoulder AG e+Ö with Markers |
Encore Medical, L.P. |
Michael Siano |
| K212883 |
07/15/2022 |
ers2 - ergoline Rehabilitation System |
ergoline GmbH |
Alexandra Lertz |
| K221433 |
07/15/2022 |
Facet 28G Universal Lancet |
Facet Technologies LLC |
James Bonds |
| K221203 |
07/14/2022 |
AHI System |
Fifth Eye Inc. |
Jennifer Baird |
| K212178 |
07/20/2022 |
Root Apex Locator |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K220827 |
07/05/2022 |
Electric Wheelchair |
Foshan Dahao Medical Technology Co.,Ltd |
Bao Yi Xie |
| K211496 |
07/27/2022 |
TransLoc 3D |
Foundation Fusion Solutions, LLC (dba CornerLoc) |
Robert Compton |
| K213507 |
07/27/2022 |
AquaA |
Fresenius Medical Care Rental Therapies Group, LLC |
Denise Oppermann |
| K220961 |
07/29/2022 |
Deep Learning Image Reconstruction |
GE Healthcare Japan Corporation |
Wang Xing |
| K221148 |
07/18/2022 |
Vivid iq |
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
Lee Bush |
| K220882 |
07/22/2022 |
Vivid E80, Vivid E90, Vivid E95 |
GE Medical Systems Ultrasound and |
Tracey Ortiz |
| K220940 |
07/22/2022 |
EchoPAC Software Only, EchoPAC Plug-in |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K220619 |
07/15/2022 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K221147 |
07/18/2022 |
Vivid T8, Vivid T9 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Lee Bush |
| K212982 |
07/29/2022 |
Medispine - Spinal Needle, Glospine - Spinal Needle |
Global Medikit Limited |
Karun Narang |
| K221877 |
07/23/2022 |
Powder-Free Nitrile Examination Glove, Non-Sterile |
GoodGloves Industries Sdn Bhd |
Yee Kam Lin |
| K213574 |
07/12/2022 |
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K221687 |
07/27/2022 |
Pegasus-X Expandable PLIF System |
GS Medical Co. Ltd. |
Sam Camp |
| K221251 |
07/29/2022 |
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) |
Guangzhou Hua Kai Electronic Technology Co., Ltd. |
Cao Ke |
| K221454 |
07/12/2022 |
Disposable Medical Nitrile Examination Gloves - Non Sterile |
Guangzhou Kangling Biotechnology Co., Ltd |
Yan Wang |
| K213498 |
07/14/2022 |
PELNAC Meshed Bilayer Wound Matrix |
Gunze Limited |
Hidenori Nishioka |
| K213143 |
07/12/2022 |
Hemoclip |
Hangzhou AGS MedTech Co., Ltd. |
Yanping Fu |
| K213405 |
07/10/2022 |
MINE ALNU (Model: Mine 2.1) |
HDT Co., Ltd |
Sung Hee Chun |
| K210069 |
07/06/2022 |
Minuteful - kidney test |
Healthy.io Ltd. |
Ron Zohar |
| K213760 |
07/29/2022 |
ABMD Software |
HeartLung Corporation |
Morteza Naghavi |
| K220671 |
07/21/2022 |
Manual Wheelchair |
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd |
Liu Zhihao |
| K203279 |
07/12/2022 |
Veuron-Brain-mN1 |
Heuron Co., Ltd. |
Dong Hoon Shin |
| K220643 |
07/08/2022 |
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; |
HTL-Strefa S.A. |
Justyna Zemigala |
| K220777 |
07/19/2022 |
Surgical face mask |
Hubei Qianjiang Kingphar Medical Material Co., Ltd |
Zhao Fusong |
| K221151 |
07/19/2022 |
Beauty LED Mask, Model: KFB265 |
Hunan Guangye Biotechnology Co., Ltd. |
Eileen Li |
| K221242 |
07/29/2022 |
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Hunan Vsmile Biotechnology Co., Ltd |
Xiaomi Tang |
| K220815 |
07/19/2022 |
BrainInsight |
Hyperfine, Inc. |
Christine Kupchick |
| K221923 |
07/28/2022 |
Swoop Portable MR Imaging System |
Hyperfine, Inc. |
Christine Kupchick |
| K221019 |
07/05/2022 |
Osteon Precision Milled Suprastructure |
Implant Solutions PTY LTD (aka Osteon Medical) |
Andrea Del Ciotto |
| K221846 |
07/11/2022 |
Artix Ballon Guiding Sheath |
Inari Medical |
Elllen Nguyen |
| K220415 |
07/12/2022 |
Protrieve Sheath |
Inari Medical, Inc. |
Kaitlyn Weinkauf |
| K220331 |
07/29/2022 |
091 Balloon Guide Catheter |
InNeuroCo Inc. |
Marc Litzenberg |
| K221763 |
07/15/2022 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K220742 |
07/15/2022 |
NxtGen Infant Transport Incubator |
International Biomedical |
Amy Pieper |
| K213409 |
07/19/2022 |
ZEUS System (Zio Watch) |
iRhythm Technologies, Inc. |
Vishal Kanani |
| K221814 |
07/15/2022 |
OK Handpiece |
Jaintek Co.,Ltd |
Jung Gun Lee |
| K221293 |
07/07/2022 |
E-Brik Visualization Assistant |
JDI Surgical, Inc. |
Dwight Lenox |
| K220184 |
07/21/2022 |
Pump Alignment Syringe |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K213914 |
07/29/2022 |
Injection Needle |
Jiangsu Vedkang Medical Science and Technology Co.,Ltd |
Ting Tang |
| K214017 |
07/14/2022 |
Examination gloves-Type A(Latex gloves) |
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
Jenny Huang |
| K221173 |
07/06/2022 |
Surgical Mask (Model: 0868F, 0866F) |
Jiangxi SanHao Medical Instruments Co.,Ltd |
Jiali Chen |
| K220500 |
07/01/2022 |
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K211385 |
07/27/2022 |
KeriFlex« MCP and PIP Finger Joint Prostheses |
Keri Medical SA |
Bernard Prandi |
| K220284 |
07/08/2022 |
Powder Free Nitrile Examination Gloves (Blue) |
KGM Gloves Sdn. Bhd. |
Ooi Loon Seng |
| K210731 |
07/18/2022 |
KLS Martin Individual Patient Solutions |
KLS-Martin L.P. |
Jennifer Damato |
| K210228 |
07/08/2022 |
KLS Martin IPS Preprosthetic |
KLS-Martin L.P. |
Jennifer Damato |
| K220566 |
07/29/2022 |
Vascette HP (hemostatic pad) |
KOAG LLC |
David Lang |
| K221853 |
07/27/2022 |
OTC DDR |
Konica Minolta Healthcare Americas, Inc |
Jan Maniscalco |
| K221430 |
07/27/2022 |
reVive Light Therapy LED Cleansing System |
LED Technologies, Inc. |
Jelena Barbaric |
| K221461 |
07/22/2022 |
10HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K221394 |
07/22/2022 |
14HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K221434 |
07/13/2022 |
17HQ701G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K220877 |
07/15/2022 |
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems |
Lumenis Be, Inc. |
Shlomit Segman |
| K212113 |
07/28/2022 |
MagXtract Collection Tube |
MagBio Genomics, Inc. |
Mothomang Mlalazi-Oyinloye |
| K203680 |
07/22/2022 |
BioFire JI Control Panel M420 |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K221337 |
07/05/2022 |
Materialise TKA Guide System |
Materialise NV |
Jenny Jones |
| K211891 |
07/22/2022 |
DM Converter - TiN coated |
Medacta International S.A. |
Stefano Baj |
| K214112 |
07/26/2022 |
Invia Ease Negative Pressure Wound Therapy (NPWT) System |
Medela AG |
Mike McAndrew |
| K221654 |
07/07/2022 |
medi pneumatic compression system (pcs)-genius (Model 652) |
medi USA, L.P. |
Moses Lipshaw |
| K210822 |
07/27/2022 |
DeepRhythmAI |
Medicalgorithmics S.A. |
Marek Dziubinski |
| K214050 |
07/01/2022 |
ENT Nasopharyngoscope and Accessories |
Medimaging Integrated Solution Inc. (MiiS) |
Jung-Yi Yen |
| K221083 |
07/12/2022 |
Smartlux Mini |
MEDMIX Co., Ltd. |
Yunseok Yu |
| K221364 |
07/11/2022 |
Mitek TIGHT-N Anchor |
Medos International SARL |
Ashley Aromando (Goncalo) |
| K220040 |
07/14/2022 |
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems |
Medos International, SARL |
Michael Liao |
| K212975 |
07/22/2022 |
MedWand |
MedWand Solutions, Inc. |
Robert Rose |
| K220480 |
07/11/2022 |
Revogene |
Meridian Bioscience, Inc |
Jack Rogers |
| K220577 |
07/29/2022 |
Dental Handpiece, Model CA160, CA160L, and CA500L |
Micro-NX Co., Ltd. |
Sojeong Park |
| K213060 |
07/20/2022 |
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K220424 |
07/08/2022 |
Through the Scope Tracheal Stent System |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K213782 |
07/08/2022 |
Single-Use Video Bronchoscopes, Digital Controller |
Micro-Tech (Nanjing) Co., Lts |
Sally He |
| K213873 |
07/07/2022 |
SkyWalker Total Knee System |
MicroPort NaviBot International LLC |
Mike Manor |
| K221235 |
07/28/2022 |
neXus Ultrasonic Surgical Aspirator System |
Misonix Inc. |
John Salerno |
| K213872 |
07/15/2022 |
ComPAS2 |
Morgan Scientific, Inc. |
Deborah Cornish |
| K221025 |
07/01/2022 |
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System |
MRI Division,Beijing Wandong Medical Technology Co.,Ltd. |
Wang Huan |
| K212407 |
07/26/2022 |
Gastric Lightguide (GLG) |
Naser Dib Gabinet Lekarksi Nasmed |
Naser Dib |
| K213813 |
07/22/2022 |
DuraFuse Clip and Applier System |
NeuraMedica Inc |
Rachel Dreilinger |
| K220127 |
07/15/2022 |
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health |
Neuronetics, Inc |
Cory Anderson |
| K220631 |
07/15/2022 |
NomadAir PMU810 |
Neurotronics, Inc. |
James "Cody" Smith |
| K221395 |
07/01/2022 |
Footmotion Plating System |
Newclip Technics |
Gaδlle Lussori |
| K221905 |
07/28/2022 |
INERTIA CONNEXX Modular Pedicle Screw System |
Nexxt Spine LLC |
Andy Elsbury |
| K220976 |
07/21/2022 |
Life Scope PT BSM-1700 Series Bedside Monitor |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K220989 |
07/29/2022 |
Next Generation NetKonnect |
Nihon Kohden Digital Health Solutions, Inc. |
Maria Pronina |
| K213521 |
07/01/2022 |
Nihon Kohden NKV-330 Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Jacqueline Villanueva |
| K220048 |
07/29/2022 |
NobelProcera Zirconia N1 Base |
Nobel Biocare Services AG |
Bernice Jim |
| K221666 |
07/14/2022 |
Normatec Go |
NormaTec Industries, LP |
Steve Henderson |
| K220171 |
07/01/2022 |
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter |
Northeast Scientific, Inc. |
Matthew Farley |
| K213385 |
07/01/2022 |
GEM |
Obsidio, Inc. |
Ehsan Jabbarzadeh |
| K221426 |
07/06/2022 |
Functional MR V1.0 |
Olea Medical SAS |
Nathalie Palumbo |
| K221773 |
07/30/2022 |
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid |
ONETEXX SDN BHD |
Freddy Low |
| K212815 |
07/06/2022 |
My3D« Personalized Pelvic Reconstruction |
Onkos Surgical |
Matthew Vernak |
| K221097 |
07/14/2022 |
SmileSeries |
Ordont Orthodontic Laboratories, Inc. |
Paul Rudzicka |
| K220317 |
07/01/2022 |
PuraPly Micronized Wound Matrix (PuraPly MZ) |
Organogenesis Inc. |
Kurdea Lyon |
| K220679 |
07/20/2022 |
Pediatric Nailing Platform Femur |
OrthoPediatrics Corp. |
Yan Li |
| K220733 |
07/29/2022 |
OptiVu ROSA MxR |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K221332 |
07/28/2022 |
OsteoCentric Spine MIS Pedicle Fastener System |
OsteoCentric Technologies |
Todd Evans |
| K211370 |
07/29/2022 |
Tablo Hemodialysis System |
Outset Medical, Inc. |
Saket Bhatt |
| K214007 |
07/27/2022 |
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc. |
Anureet Singh |
| K221409 |
07/25/2022 |
Paneffort 3-ply Surgical and Procedural Masks |
Paneffort, LLC |
Harry No Last Name Provided |
| K221502 |
07/26/2022 |
Parcus Synd-EZ SS |
Parcus Medical, LLC |
Vasavi Vora |
| K214080 |
07/20/2022 |
Pentaflush |
PENTAFERTE ITALIA S.R.L. |
Rosa Di Gioia |
| K210902 |
07/27/2022 |
EliA Ro52, EliA Ro60 |
Phadia AB |
Sheryl Skinner |
| K213922 |
07/22/2022 |
FX SPS |
Pixee Medical |
Agathe Joet |
| K211720 |
07/18/2022 |
Planmed Clarity 2D, Planmed Clarify S |
Planmed Oy |
Niina Vuorikallas |
| K220573 |
07/09/2022 |
Noodle |
Pourang Bral, DDS, LLC |
Pourang Bral |
| K221254 |
07/27/2022 |
Hummingbird Tympanostomy Tube System |
Preceptis Medical, Inc. |
Steve Anderson |
| K220862 |
07/14/2022 |
E-GPS Navigated Instruments |
Precision Spine, Inc. |
Michael Dawson |
| K221525 |
07/22/2022 |
PreXion3D Explorer PRO |
PreXion Corporation |
Hiroaki Takahashi |
| K221567 |
07/26/2022 |
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) |
Qingdao Hisense Medical Equipment Co., Ltd. |
Li Mingcheng |
| K220808 |
07/25/2022 |
Tigertriever 13 Revascularization Device |
Rapid Medical Ltd. |
Orit Yaniv |
| K221234 |
07/22/2022 |
TargetCool |
RecensMedical Inc. |
Yeonui Lee |
| K220348 |
07/14/2022 |
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V |
Remex Medical Corporation |
Chuang Shih-Chang |
| K213360 |
07/05/2022 |
SleepCheckRx |
ResApp Health |
Neroli Anderson |
| K221898 |
07/28/2022 |
Gastrointestinal Boundary Identifier (GIBI HD) |
ReShape Lifesciences |
Michelle Ravert |
| K220486 |
07/22/2022 |
Kentrospine PSS Pedicle Screw System |
Rivarp Medical Private Limited |
Sushma N.R |
| K213822 |
07/06/2022 |
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| DEN210032 |
07/26/2022 |
AccuMeasure System |
RQMIS Inc. |
Barry Sands |
| K221033 |
07/06/2022 |
UniPrime A, UniPrime E, UniPrime E/C |
S&C Polymer Silicon- und Composite SpezialitΣten GmbH |
Christian B÷ttcher |
| K212783 |
07/08/2022 |
ProstatID |
ScanMed, LLC |
Randall Jones |
| K213761 |
07/19/2022 |
Joule diVa System |
Sciton, Inc |
Jay M Patel |
| K221803 |
07/18/2022 |
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. |
SEDECAL SA |
Ma Luisa Gomez de Aguero |
| K221271 |
07/27/2022 |
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Shandong Maida Medical Technology Co.,Ltd. |
Kitty Xu |
| K220183 |
07/21/2022 |
Sterile Safety Syringes for Single Use (Retractable) |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Liu Hualong |
| K220185 |
07/11/2022 |
Sterile Safety Insulin Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd. |
Liu Hualong |
| K221363 |
07/20/2022 |
AF Laser |
ShenB Co Ltd |
Sunny Kang |
| K213009 |
07/08/2022 |
Transcranial Doppler Ultrasound System |
Shenzhen Delica Medical Equipment Co., Ltd. |
Zhenhua Xiao |
| K220886 |
07/27/2022 |
Upper Arm Type Blood Pressure Monitor |
Shenzhen Jamr Technology Co.,Ltd |
Luo Fusheng |
| K220161 |
07/20/2022 |
Biofeedback Nerve and Muscle Stimulator |
Shenzhen Konmed Technology Co.,Ltd. |
ShuiShan Yin |
| K220248 |
07/01/2022 |
Home use hair removal device |
Shenzhen Mareal Tech Co., Ltd |
Liu Libin |
| K213799 |
07/12/2022 |
N Series Patient Monitors |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Li Lei |
| K221679 |
07/07/2022 |
IPL Hair Remover, Model: G993, G996, G998 and G885 |
Shenzhen Mywin Technology Co., Ltd. |
Meiyun Liu |
| K213056 |
07/07/2022 |
LED Facial Mask |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K221246 |
07/07/2022 |
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) |
Shenzhen Semlamp Intelligent Technology Co., Ltd |
Qi Wenjun |
| K211150 |
07/01/2022 |
Dental diode laser, SOGA Laser, ILaser II |
Shenzhen Soga Technology Co., Ltd. |
Tse Adrian |
| K221922 |
07/28/2022 |
Trinias |
Shimadzu Corporation Medical Systems Division |
Koichi Kataoka |
| K220095 |
07/11/2022 |
ANNE Sleep |
Sibel Inc. |
Peter Xu |
| K221516 |
07/19/2022 |
ARTIS icono (Ceiling Configuration) |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K220814 |
07/12/2022 |
NAEOTOM Alpha, Scan&GO Software |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K221727 |
07/13/2022 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K221625 |
07/01/2022 |
2-Way 100% Silicone ClearTract Catheter |
Silq Technologies Corporation |
Sigi Caron |
| K221939 |
07/26/2022 |
Cemented Round Patella with JRNY Pegs |
Smith & Nephew, Inc. |
Madison Padgett |
| K211176 |
07/01/2022 |
Smith & Nephew Hip Systems |
Smith & Nephew, Inc. |
Crystal Higgenbottom-Shaffer |
| K210354 |
07/13/2022 |
SNUCONE Bone Level Implant System |
SNUCONE Co., LTD. |
Ji Eun Song |
| K213881 |
07/21/2022 |
Celerity Incubator |
STERIS Corporation |
Gregory Land |
| K220771 |
07/07/2022 |
Stratasys TrueDent |
Stratasys Ltd |
Melanie Glennon |
| K221098 |
07/12/2022 |
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit |
Stryker Corporation |
Maya Schiel |
| K221346 |
07/08/2022 |
Stryker VariAx 2 MIS Calcaneus |
Stryker GmbH |
Jonathan Schell |
| K220901 |
07/29/2022 |
S-Core Implant System |
Subchondral Solutions, Inc. |
Michael Kolber |
| K213576 |
07/15/2022 |
Tatum Surgical Dental Implant System |
Suncoast Dental, Inc. dba Tatum Surgical |
Tony Fiorello |
| K212614 |
07/18/2022 |
Ultrasonic Scalpel System |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K212819 |
07/06/2022 |
Disposable Biopsy Refill Needle |
Suzhou Leapmed Healthcare Corporation |
Yu Zhu |
| K212822 |
07/06/2022 |
Disposable Coaxial Biopsy Needle |
Suzhou Leapmed Healthcare Corporation |
Yu Zhu |
| K212820 |
07/06/2022 |
Disposable Semi Automatic Biopsy Instrument |
Suzhou Leapmed Healthcare Corporation |
Yu Zhu |
| K213488 |
07/01/2022 |
Bladder Scanner, Model Name:M5 |
Suzhou Peaksonic Medical Technology Co., Ltd. |
Calvin Ma |
| K203134 |
07/01/2022 |
Hanger Cranial Band 3D |
Symbion Logistics, LLC |
Roselle Abad |
| K201440 |
07/08/2022 |
ROTEM sigma Thromboelastometry System |
Tem Innovations GmbH |
David Jacob |
| K221176 |
07/01/2022 |
Insulin Pen Needle |
Tianjin Huahong Technology Co., Ltd. |
Yuan Ying |
| K220475 |
07/06/2022 |
Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) |
Tianjin Huahong Technology Co., Ltd. |
Yuan Ying |
| K220534 |
07/07/2022 |
Wet Essential95 Personal Lubricant |
Trigg Laboratories, Inc. |
Marla Bolden |
| K212472 |
07/07/2022 |
AgeJet |
Triworks Group SRL |
Elio Piero Berchicci |
| K213961 |
07/14/2022 |
TruAbutment DS, TruBase |
TruAbutment Inc. |
Hyeonhwa An |
| K221909 |
07/01/2022 |
J-Temp |
Ultradent Products, Inc. |
Matthew Buck |
| K213357 |
07/19/2022 |
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor |
Verily Life Sciences LLC |
Dinesh Puppala |
| K221512 |
07/20/2022 |
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) |
Vieworks Co., Ltd. |
Kevin Oh |
| K221030 |
07/15/2022 |
Model 9100 PFT/DICO |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K220439 |
07/25/2022 |
Viz SDH |
Viz.ai, Inc. |
Vi Ma |
| K220743 |
07/05/2022 |
CediTEC |
VOCO GmbH |
M. Th. Plaumann |
| K221572 |
07/26/2022 |
VyPlate Anterior Cervical Plate System |
Vy Spine, LLC |
Jordan Hendrickson |
| K221794 |
07/20/2022 |
Vario-Cup System |
Waldemar Link GmbH & Co. KG |
Pia Mueller |
| K211543 |
07/21/2022 |
Wei Nasal Jet Tube |
Well Lead Medical Co., LTD. |
Caroline Gong |
| K221196 |
07/22/2022 |
Disposable Medical Face Mask (ear loop) |
Xiantao Topmed Nonwoven Protective Products Co., Ltd. |
Vivian Zhu |
| K220906 |
07/22/2022 |
SECURE-LOCK |
Xiros Ltd |
Steve Curran |
| K221230 |
07/28/2022 |
TRON |
Xoran Technologies LLC |
Mark McGarrow |
| K220064 |
07/22/2022 |
Synergy Marble (Model: Opasm) |
YRS Group Inc |
Raphael Arvili |
| K220063 |
07/28/2022 |
Single Use Cytology Brush |
Zhejiang Chuangxiang Medical Technology Co., Ltd. |
Lucius Long |
| K221026 |
07/01/2022 |
Power Wheelchair |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd |
Leo Zheng |
| K221229 |
07/16/2022 |
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves |
Zibo Blue Sail Health Technology Co., Ltd |
Xu Shulong |
