| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K212263 |
03/25/2022 |
Luna G3 BPAP System |
3B Medical, Inc. |
Yasser Estafanous |
| K214093 |
03/30/2022 |
VSP Bolus |
3D Systems |
Benjamin Johnson |
| K213779 |
03/16/2022 |
Customize |
3D-Side SA |
Laurent Paul |
| K213932 |
03/02/2022 |
A-dec 300, A-dec 500 |
A-dec, Inc. |
Raquel Peregrino de Brito |
| K220006 |
03/02/2022 |
angioLOCK Polymer Ligating Clip |
A2 Medical Systems, LLC |
Robert Hall |
| K203530 |
03/18/2022 |
Albumin BCP2 |
Abbott Ireland Diagnostics Division |
Suzanne Cheang |
| K210452 |
03/22/2022 |
Creatinine2 |
Abbott Ireland Diagnostics Division |
Magdalena Suszko |
| K213486 |
03/10/2022 |
GLP systems Track |
Abbott Laboratories |
Michele Smith Waheed |
| K220340 |
03/09/2022 |
Amplatzer Steerable Delivery Sheath |
Abbott Medical |
Emily Jallen |
| K213721 |
03/21/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K214043 |
03/14/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K213849 |
03/09/2022 |
SafeOp 2: Neural Informatix System |
Alphatec Spine, Inc. |
David Gramse |
| K212596 |
03/01/2022 |
Sterile Latex Surgical Gloves Powder Free |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K213522 |
03/22/2022 |
AMSafe Pre-Filled Normal Saline Flush Syringe |
Amsino International, Inc. |
Jane Gao |
| K212999 |
03/21/2022 |
Multi-Functional Electrosurgical Knife |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| K212148 |
03/10/2022 |
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products LLC |
Donald Cronk |
| K212888 |
03/31/2022 |
Golnit Nylon Monofilament Suture |
Antarma LLC dba Golnit Sutures |
Armine Badalyan |
| K213887 |
03/29/2022 |
GAL-1A Plus Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K211043 |
03/31/2022 |
Alexis Contained Extraction System |
Applied Medical Resources Corporation |
Apeksha Shanbhag |
| K211132 |
03/18/2022 |
ARISTE AB Mesh |
Ariste Medical LLC |
Olaf Schulz |
| K203744 |
03/14/2022 |
Arterys MICA |
Arterys Inc. |
Sharon Cholowsky |
| K213200 |
03/21/2022 |
Solus Gold Embolization Device |
Artio Medical, Inc. |
Erdie De Peralta |
| K212057 |
03/01/2022 |
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS |
ArtVentive Medical Group, Inc. |
Anil Bhalani |
| K213589 |
03/24/2022 |
FUBUKI XF Neurovascular Long Sheath |
Asahi Intecc Co., Ltd. |
Tomoya Eguchi |
| K220678 |
03/31/2022 |
APX-24 Portable X-ray System |
Aspenstate INC |
Albert Kim |
| K214047 |
03/30/2022 |
EL CAPITAN Anterior Lumbar Interbody Fusion System |
Astura Medical |
Parker Kelch |
| K200828 |
03/22/2022 |
Athelas Home |
Athelas Inc. |
Tanay Tandon |
| K211324 |
03/14/2022 |
2.4mm Distal Radius System |
Auxein Medical Private Limited |
Gaurav Luthra |
| K213778 |
03/03/2022 |
IV Administration Set |
B.Braun Medical Inc. |
Tracy Larish |
| K213957 |
03/11/2022 |
Demetra Dermatoscope BDEM-01 |
Barco NV |
Imke Storm |
| K213896 |
03/30/2022 |
BD Trek Powered Bone Biopsy System |
Bard Peripheral Vascular |
Courtney Willson |
| K214016 |
03/18/2022 |
15L Cycler Drainage Bag |
Baxter Healthcare Corporation |
Maninee Patel |
| K220178 |
03/23/2022 |
Total Immunoglobulin E (IgE) |
Beckman Coulter, Inc. |
Veronica Colinayo |
| K220584 |
03/31/2022 |
BD Cathena Safety IV Catheter |
Becton Dickinson Infusion Therapy Systems Inc. |
Paul Holman |
| K212499 |
03/09/2022 |
BD Insulin Syringe (0.3mL) |
Becton, Dickinson and Company |
Mark William |
| K213616 |
03/23/2022 |
BD Surgiphor Antimicrobial Irrigation System |
Becton, Dickinson and Company |
Shelley Wilcox |
| K211420 |
03/14/2022 |
Stasis Gel |
Belport Company, Inc., Gingi-Pak |
Mohammed Islam |
| K213948 |
03/17/2022 |
OxyMinder |
Bio-Med Devices, Inc. |
Ken K Close |
| K212153 |
03/25/2022 |
Biobeat Platform, BB-613WP Patch |
BioBeat Technologies Ltd. |
Johanan May |
| K213671 |
03/03/2022 |
Astroglide Sensual Strawberry Personal Lubricant |
BioFilm Inc. |
Jennifer Keller |
| K212461 |
03/15/2022 |
VITEK MS PRIME |
bioMerieux, Inc. |
Nathan Hardesty |
| K213672 |
03/28/2022 |
T3 Pro Implants |
Biomet 3i LLC |
Krupal Patel |
| K213712 |
03/11/2022 |
Pectus Support Bar System |
Biomet Microfixation |
Mark Wladkowski |
| K211438 |
03/18/2022 |
OPTRELL Mapping Catheter with TRUEref Technology |
Biosense Webster, Inc. |
John Jimenez |
| K220255 |
03/29/2022 |
REAL INTELLIGENCE CORI |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K212040 |
03/11/2022 |
RI.HIP MODELER |
Blue Belt Technologies, Inc. |
Michael Gosha |
| K211155 |
03/09/2022 |
Auto CPAP System |
BMC Medical Co., Ltd. |
Amy Wang |
| K220629 |
03/24/2022 |
Emerge Monorail PTCA Dilatation Catheter |
Boston Scientific |
Aoife O'Flaherty |
| K220153 |
03/18/2022 |
Needle Stimulator (Model: RJNS6-1) |
Bozhou Rongjian Medical Appliance Co.,Ltd. |
Wu Zhifang |
| DEN200042 |
03/29/2022 |
BrainTemp Neonate System (BTNeo System) |
Brain Temp Inc. |
David Anderson |
| K211639 |
03/07/2022 |
BTL-785W |
BTL Industries Inc. |
David Chmel |
| K212723 |
03/04/2022 |
BTL-995-rTMS |
BTL Industries Inc. |
David Chmel |
| K220362 |
03/25/2022 |
LE-12CH |
CAF Medical Solutions Inc. |
Oscar Arriaga Yamin |
| K212960 |
03/22/2022 |
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K220018 |
03/03/2022 |
MR Elastography; MZEK-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K213834 |
03/18/2022 |
Cardio Flow Peripheral Guide Wire |
Cardio Flow, Inc. |
Michael J. Kallok |
| K220109 |
03/01/2022 |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
Nikita Basandra |
| K213907 |
03/14/2022 |
CareGUARD Sterilization Wrap |
Care Essentials Pty Ltd |
Abhay Sinha |
| K213568 |
03/23/2022 |
DRX-Rise Mobile X-ray System |
Carestream Health |
Gina Maiolo |
| K213699 |
03/30/2022 |
CareTaker Monitor App |
Caretaker Medical, LLC |
Jeff Pompeo |
| K213314 |
03/15/2022 |
CerusEndo Microcatheter (027) |
Cerus Endovascular, Inc. |
Lori Adels |
| K213910 |
03/10/2022 |
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs |
Changzhou Universal Medical Equipment Co. Ltd |
Cai Jin Fu |
| K213135 |
03/02/2022 |
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge |
Chirurgie Innovation |
Guillaume Noury |
| K220182 |
03/30/2022 |
AggerisÖ-C |
Clariance |
MΘlody La Porte |
| K213729 |
03/26/2022 |
Clover Glove |
Clover Glove Company Limited |
Pongsin Pongwachirint |
| K203637 |
03/08/2022 |
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) |
Coloplast |
Delaney McDougal |
| K211911 |
03/10/2022 |
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets |
Coloplast Corp |
Angela Kilian |
| K213354 |
03/11/2022 |
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart |
ConMed Corporation |
Lisa Anderson |
| K212631 |
03/17/2022 |
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses |
Contamac Ltd. |
Rob McGregor |
| K220506 |
03/07/2022 |
SkinPen Precision System |
Crown Aesthetics |
Marie Fogartie |
| K213461 |
03/24/2022 |
AviClear Laser System |
Cutera, Inc. |
Amogh Kothare |
| K212891 |
03/18/2022 |
TempSure System |
Cynosure, LLC |
Michael King |
| K213553 |
03/02/2022 |
Giraffe Incubator Carestation CS1 |
Datex Ohmeda Inc. |
Shiwani Zalpuri |
| K213551 |
03/02/2022 |
Giraffe Omnibed Carestation CS1 |
Datex Ohmeda Inc. |
Shiwani Zalpuri |
| K212281 |
03/04/2022 |
Surgical Trays |
Dentsply Sirona Inc. |
Courtney Clark |
| K213563 |
03/18/2022 |
DePuy Synthes Radial Head Replacement System |
DePuy Synthes |
Quinn McCarthy |
| K213492 |
03/24/2022 |
Dib UltraNav Transseptal Catheter System |
Dib UltraNav Medical, LLC |
Lowry Barfield |
| K211681 |
03/30/2022 |
EON |
Dominion Aesthetic Technologies, Inc. |
Ahmed Mohammed |
| K213843 |
03/31/2022 |
Nitrile Examination Gloves |
Dong Tai City Huayi Gloves Co.,Ltd. |
Huamei Wang |
| K211808 |
03/04/2022 |
Medcare Powder-Free Blue Nitrile Patient Examination Gloves |
Dongguan Grinvald Technology Co., Ltd. |
Anna Roxana Grinvald |
| K212464 |
03/30/2022 |
Dukal Corporation AAMI Level 4 Open-Back Protective Gown |
Dukal Corporation |
Megan Quevedo |
| K210321 |
03/29/2022 |
Dukal Corporation Level 1 Pediatric Face Mask |
Dukal Corporation |
Megan Quevedo |
| K203237 |
03/18/2022 |
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown |
Dukal Corporation |
Megan Quevedo |
| K214101 |
03/23/2022 |
Project E Beauty LED Light Therapy Mask (Model: PE730) |
Duplex International Trading Limited |
Patrick Lee |
| K213894 |
03/14/2022 |
DWFritz ASM2000 |
DWFritz Automation, Inc. |
Curtis Smith |
| K220627 |
03/18/2022 |
SURGIVISIO Device |
Ecential Robotics |
Mathilde Saulpic |
| K212851 |
03/16/2022 |
EchoSK and EchoSGyn modules for EchoS Family devices |
Echolight S.p.A |
Giuseppe Criscenti |
| K213658 |
03/11/2022 |
DEKA SMARTPERIO |
El.En Electronic Engineering Spa |
Paolo Peruzzi |
| K201351 |
03/11/2022 |
Maxima Surgical Gown |
Elevate Textiles |
Nathaniel Terry |
| K220519 |
03/24/2022 |
Erchonia Zerona Z-Bed |
Erchonia Corporation |
Travis Sammons |
| K220275 |
03/18/2022 |
EMERGE Anterior Cervical Plate System |
Evolution Spine |
Todd Wallenstein |
| K212356 |
03/04/2022 |
Exactech« Equinoxe« Laser Cage Glenoid |
Exactech, Inc. |
Kenneth C. Maxwell |
| K220655 |
03/24/2022 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, Inc |
Robert Jaramillo |
| K220327 |
03/04/2022 |
geko W-3 |
Firstkind Limited |
Neil Buckley |
| K212371 |
03/18/2022 |
F&P Evora Full Face Mask |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K213579 |
03/02/2022 |
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph |
FONA S.r.l |
Luigi Germano |
| K213457 |
03/02/2022 |
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 |
Fort Defiance Industries LLC |
Chris Coleman |
| K202075 |
03/11/2022 |
Dental Electric Motor |
Foshan CICADA Dental Instrument Co, Ltd. |
Juan Liu |
| K212698 |
03/02/2022 |
Plus Medical Isolation Gown Level 3 |
Foshan Nanhai Plus Medical Co Ltd |
Eric Li |
| K210074 |
03/01/2022 |
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable |
Fresenius Kabi AG |
Keith Dunn |
| K210073 |
03/01/2022 |
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo |
Fresenius Kabi AG |
Keith Dunn |
| K210075 |
03/01/2022 |
Vigilant Software Suite û Vigilant Master Med |
Fresenius Kabi AG |
Keith Dunn |
| K211843 |
03/04/2022 |
PolyLock Plating System |
Fusion Orthopedics |
Eli Jacobson |
| K213980 |
03/15/2022 |
Peridot Spinal Interbody System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K213725 |
03/11/2022 |
CardIQ Suite |
GE Medical Systems SCS |
Yonghui Han |
| K214039 |
03/22/2022 |
LOGIQ P10, LOGIQ P9, LOGIQ P8 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K212652 |
03/02/2022 |
Sterile Syringe with Fixed Safety Needle for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| K220096 |
03/09/2022 |
Genesys Spine 3DP Lumbar Interbody System |
Genesys Spine |
Chloe Lance |
| K211780 |
03/09/2022 |
ZEN-2090 Turbo |
Genoray Co., Ltd. |
Sookyung Choi |
| K211887 |
03/11/2022 |
Personal Kinetigraph (PKG) System Gen 2 Plus |
GKC Manufacturing Pty Ltd |
Jim Quackenbush |
| K212365 |
03/01/2022 |
BoneView |
Gleamer |
Antoine Tournier |
| K213005 |
03/11/2022 |
Apollo Ankle Fracture Plating System |
GLW Medical Inc |
Arundhati Radhakrishnan |
| K210693 |
03/22/2022 |
PLEXR PLUS |
GMV S.r.l. |
Andrea Cancelli |
| K201861 |
03/02/2022 |
Bio Fluff System |
Gnali Bocia S.R.L. |
Katy Gnali |
| K211365 |
03/24/2022 |
Alio Medical Remote Monitoring System |
Graftworx, Inc. dba Alio |
David Kuraguntla |
| K220240 |
03/31/2022 |
Vinyl Co-Polymer Powder-free Examination Gloves, Black |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K210352 |
03/27/2022 |
GGM Breathing Circuit Bacterial Filter |
Great Group Medical Co., Ltd. |
Kiki Hung |
| K220187 |
03/25/2022 |
Medical Surgical Mask (Model: JM92, JM92B) |
Guangdong Jia Mei Biological technology Co.Ltd |
Jiali Chen |
| K213848 |
03/25/2022 |
Medical nitrile examination gloves (Model: JL001) |
Guangdong Jiali Pharmaceutical Co.,Ltd |
Jiali Chen |
| K213851 |
03/09/2022 |
Disposable Medical Nitrile gloves |
Guangdong Xingcan Brothers Medical Technology Co.,Ltd |
Suhai Yin |
| K210367 |
03/10/2022 |
D-Laser Blue, D-Laser 16 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yang Yunfeng |
| K211787 |
03/03/2022 |
Hemoclip |
Hangzhou AGS MedTech Co., Ltd. |
Yanping Fu |
| K213736 |
03/31/2022 |
Medical Face Mask |
Hangzhou Runheng Medical Co., Ltd. |
Yaya Lu |
| K214103 |
03/22/2022 |
Shani Darden LED light therapy mask |
Harpar Grace International |
Alana Marie Chalmers |
| K212623 |
03/16/2022 |
Healgen Strep A Rapid Test Strip (Throat Swab) |
Healgen Scientific, LLC |
Jianqiu Fang |
| K214091 |
03/02/2022 |
Dental Image Plate Scanner, Model DFC-4T-SMART |
Hefei DentaFilm Medical Equipment Co., Ltd |
Ming Chang Qiu |
| K212330 |
03/14/2022 |
Yadu Medical Face Mask (Level 1) |
HeNan YADU Industrial Co., Ltd. |
Charles Shen |
| K220492 |
03/23/2022 |
COPAL exchange G hip spacer |
Heraeus Medical GmbH |
Heike Gustke |
| K220376 |
03/09/2022 |
Acetabular Dome Hole Plug |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Lin Song |
| K212187 |
03/01/2022 |
Restoration« Modular Hip System |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Margaret Klippel |
| K212726 |
03/23/2022 |
Disposable Medical Surgical Mask |
Hubei Huaqiang High-Tech Co., Ltd. |
Jing Yang |
| K214087 |
03/08/2022 |
Medical Face Mask |
Hubei Medlink Healthcare Co., Ltd |
Sophie Liu |
| K210718 |
03/23/2022 |
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
Junfeng Zhang |
| K213820 |
03/25/2022 |
BALTEUM - ONEÖ Lumbar Plate System |
Huvexel Co., Ltd |
Sung Kyu Hur |
| K212955 |
03/15/2022 |
Fit Pro Breast Pump |
Hygeia II Medical Group, Inc. |
Brett Nakfoor |
| K212676 |
03/03/2022 |
Osteon Precision Milled Suprastructure |
Implant Solutions PTY LTD (Osteon Medical) |
Andrea Del Ciotto |
| K220260 |
03/31/2022 |
Hercules Syndesmosis Implant System |
In2Bones USA, LLC |
Christine Scifert |
| K220600 |
03/25/2022 |
Artix Thrombectomy Device |
Inari Medical |
Ellen Nguyen |
| K212165 |
03/10/2022 |
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath |
Innovative Health, LLC. |
Rick Ferreira |
| K210811 |
03/01/2022 |
Dynamyx Digital Pathology Software |
Inspirata, Inc. |
Richard Morroney |
| K210422 |
03/30/2022 |
INTAI Surgical Mask (non-sterile) |
INTAI Technology Corp. |
Dale Chang |
| K201229 |
03/11/2022 |
Intai Anatomic Locking Plate and Screw System |
Intai Technology Corporation |
Dale Chang |
| K220453 |
03/24/2022 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc. |
Anne Mulvihill |
| K213355 |
03/25/2022 |
Toro-L Interbody Fusion System |
Integrity Implants Inc. |
Alexa Kamer |
| K213823 |
03/16/2022 |
Intera Refill Kit |
Intera Oncology, Inc. |
Michael Gaisford |
| K220422 |
03/11/2022 |
Dental sensors NanoPix1, NanoPix2 |
iRay Technology Taicang Ltd. |
Guo Wu |
| K213646 |
03/29/2022 |
Focus HD 35 Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K213529 |
03/29/2022 |
Focus HD 43 Detector |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K213592 |
03/23/2022 |
Iridex 810 Laser |
Iridex Corporation |
Bill Hyatt |
| K203839 |
03/21/2022 |
WatchPAT200U (WP200U) |
Itamar Medical, Ltd. |
Efrat Litman |
| K213121 |
03/15/2022 |
Disposable Nitrile Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K202437 |
03/25/2022 |
Infusion Sets for Single Use |
Jiangsu Suyun Medical Materials Co., Ltd. |
Guangning Xu |
| K213038 |
03/10/2022 |
Infrared Forehead Thermometer, model: HS-9802D |
Jiaxing Shangjia Intelligence Technology Co., Ltd. |
Lou Yongwei |
| K213189 |
03/01/2022 |
Wrist-type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co., Ltd |
Dandan Huang |
| K220726 |
03/16/2022 |
K Clear |
K Line Europe GmbH |
Sherif Kandil |
| K220637 |
03/25/2022 |
3 Ply Medical Grade Single Use Procedural Disposable Face Mask |
KDI Med Supply |
Yolanda Davis |
| K211919 |
03/04/2022 |
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat |
Kinetic Innovative Seating System LLC |
Susan Farricielli |
| K202046 |
03/01/2022 |
LOTA SLA Dental Implant System and LOTA HA Dental Implant System |
KJ Meditech Co., Ltd. |
Hyukki Moon |
| K220215 |
03/26/2022 |
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) |
KSG MEDICARE Sdn. Bhd. |
Jennifer Yeo |
| K213147 |
03/28/2022 |
CERABIEN MiLai |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K213441 |
03/09/2022 |
PathLoc Lumbar Interbody Fusion Cage System |
L&K BioMed Co., Ltd. |
Kang-Keun Lee |
| K213860 |
03/23/2022 |
ArthroFree Wireless Surgical Camera System |
Lazurite Holdings LLC |
Patrick Polito |
| K212894 |
03/31/2022 |
PhasTIPP |
LeMaitre Vascular Inc. |
Anurag Gadgil |
| K213678 |
03/22/2022 |
Powder Free Blue Nitrile Examination Gloves |
Lienteh Technology Sdn Bhd |
Irsyad Mazuki |
| K220025 |
03/31/2022 |
ARx« Spinal System |
Life Spine, Inc. |
Angela Batker |
| K210823 |
03/18/2022 |
LYMA Laser |
LYMA Life Ltd. |
Simon Goff |
| K213751 |
03/10/2022 |
NextARÖ TKA Platform My Knee PPS |
Medacta International S.A. |
Stefano Baj |
| K203738 |
03/14/2022 |
Qitexio |
Medex |
Sandra Thiolliere |
| K210037 |
03/25/2022 |
Pluski Safe 1 Safety IV Catheter |
Mediplus (India) Limited |
Alka Goel |
| K213567 |
03/02/2022 |
Medline UNITE Calcaneal Fracture Plating System |
Medline Industries, LP |
Jennifer Mason |
| K220511 |
03/22/2022 |
Medline UNITE IM Fibula Implant |
Medline Industries, LP |
Jennifer Mason |
| K220374 |
03/08/2022 |
EXPEDIUM VERSE« Fenestrated Screw System (Sterile Fenestrated Screws) |
Medos International SARL |
Megan Smith |
| K203376 |
03/02/2022 |
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G |
Medtecs (Taiwan) Corp. |
William Yang |
| K213246 |
03/21/2022 |
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long |
Medtronic Xomed, Inc. |
Alexandra Oliver |
| K220379 |
03/03/2022 |
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System |
Medynus Inc. |
David Shin |
| K213434 |
03/08/2022 |
Elation Pulmonary Balloon Dilation Catheter |
Merit Medical Systems, Inc. |
David Thomas |
| K220529 |
03/18/2022 |
Merits P335 Powered Wheelchair |
Merits Health Products Co., LTD. |
Martin Tseng |
| K220247 |
03/29/2022 |
Guidewire Locking Device |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K211776 |
03/01/2022 |
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K213127 |
03/02/2022 |
ReNew Disposable Scissor Tips |
Microline Surgical, Inc. |
Scott Marchand Davis |
| K211120 |
03/31/2022 |
ERIC Retrieval Device |
MicroVention Inc. |
Stephanie Onstot |
| K210528 |
03/16/2022 |
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit |
Millennium Medical Technologies Inc (DBA Cellmyx) |
Wangzhong Sheng |
| K211183 |
03/02/2022 |
Sugita AVM Microclips |
Mizuho America, Inc. |
Richard Chadwick |
| K213790 |
03/14/2022 |
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 |
Mobility Source Medical Technology Co., Ltd. |
Evan Wong |
| K210315 |
03/17/2022 |
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps |
Modern Medical Equipment Manufacturing, LTD. |
Jerry Cheung |
| K212149 |
03/03/2022 |
MyndMove 2.0 |
MyndTec Inc. |
Yesmil Pena |
| K212231 |
03/25/2022 |
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Donny Lee |
| K213687 |
03/11/2022 |
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch |
NeoCoil, LLC |
Katie Gonzalez |
| K220181 |
03/22/2022 |
StealthFix Intraosseous Fixation System |
Nextremity Solutions, Inc. |
Elise Fox |
| K212498 |
03/18/2022 |
Stable-L Standalone Lumbar Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K220291 |
03/31/2022 |
NEXXT SPINE NAVIGATION System |
Nexxt Spine LLC |
Andy Elsbury |
| K212965 |
03/10/2022 |
Smile-100 System |
Niramai Health Analytix Private Limited |
Geetha Manjunath |
| K220354 |
03/24/2022 |
Disposable Medical Synthetic Nitrile Examination Gloves |
Niujian Technology Co., Ltd |
Alan Chow |
| K220353 |
03/31/2022 |
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs |
Niujian Technology Co., Ltd |
Alan Chow |
| K213562 |
03/25/2022 |
DTX Studio Clinic 3.0 |
Nobel Biocare AB |
Wim Vrydag |
| K211658 |
03/03/2022 |
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T |
NORAS MRI products GmbH |
Manuel Noras |
| K212720 |
03/03/2022 |
nordicDSC |
NordicNeurolab AS |
Chandana Gurung Bhandari |
| K213279 |
03/02/2022 |
NovaGuide 2 Intelligent Ultrasound |
NovaSignal Corporation |
Raajdeep (Raaj) Venkatesan |
| K213623 |
03/16/2022 |
iTEAR100 Neurostimulator |
Olympic Ophthalmics |
Michael Gertner |
| K220069 |
03/09/2022 |
4K UHD LCD Monitor OEV321UH |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K220049 |
03/14/2022 |
Optimotion Implants Porous Metal-Backed Patella |
Optimotion Implants, LLC |
Andy Rynearson |
| K220315 |
03/11/2022 |
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K213590 |
03/01/2022 |
Blue Topaz Sacroiliac Screw System |
Osseus Fusion Systems, LLC |
Jonathan Rosen |
| K213415 |
03/28/2022 |
OSSIOfiber Suture Anchor |
OSSIO Ltd. |
Taly Lindner |
| K202675 |
03/04/2022 |
InRoad« Dental Synthetic Bone Graft |
Osteogene Tech Corp |
Daniel S. Oh |
| K210365 |
03/04/2022 |
Second Opinion |
Pearl Inc. |
Bill Birdsall |
| K213516 |
03/03/2022 |
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei |
Philips Medical Systems Nederland, B.V. |
Jan van de Kerkhof |
| K211900 |
03/04/2022 |
Patient Information Center iX |
Philips Medizin Systeme B÷blingen GmbH |
Peng Cui |
| K220324 |
03/16/2022 |
AccuFit Lateral 2-Hole Plate |
Precision Spine, Inc. |
Michael Dawson |
| K213370 |
03/30/2022 |
VERIQA |
PTW-Freiburg Physikalisch-Technische-Werkstaetten |
Sandor-Csaba Ats |
| K220426 |
03/16/2022 |
Fiber Dust PRO |
Quanta System Spa |
Dario Bandiera |
| K212159 |
03/30/2022 |
Shield System |
Radiaction Ltd. |
Jonathan Yifat |
| K213400 |
03/01/2022 |
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry |
RB Health (US) |
Lisa Burns |
| K220674 |
03/31/2022 |
TargetCool |
RecensMedical Inc. |
Yeonui Lee |
| K202266 |
03/29/2022 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K213836 |
03/11/2022 |
Intracept Intraosseous Nerve Ablation System |
Relievant Medsystems, Inc. |
Thomas A Slater |
| K213534 |
03/11/2022 |
PHantom Trilogy |
Resurgeonz LLC |
Julie LaLonde |
| K212916 |
03/24/2022 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Rimba Glove SDN BHD |
Zahari Bin Darus |
| K213566 |
03/10/2022 |
ClearRead Xray Pneumothorax |
Riverain Technologies, Inc. |
Jonathan Jackson |
| K202903 |
03/24/2022 |
Surgical Face Mask |
Rizhao Sanqi Medical & Health Articles Co., Ltd. |
Julia Yu |
| K210546 |
03/31/2022 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
Jane Phillips |
| K212037 |
03/28/2022 |
SancDam Latex Oral Dam |
Sanctuary Health Sdn. Bhd. |
Sumethi Selavaraju |
| K212709 |
03/15/2022 |
VoqX Electronic Stethoscope |
Sanolla Ltd. |
Doron Adler |
| K214057 |
03/31/2022 |
STATIM 6000B Vacuum Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K220228 |
03/18/2022 |
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs |
Shandong Blue Sail Health Technology Co., Ltd |
Shi Haifeng |
| K213994 |
03/04/2022 |
Flexible Block |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K212920 |
03/11/2022 |
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use |
Shandong Weigao Group Medical Polymer Co., Ltd. |
Lina Liu |
| K212626 |
03/23/2022 |
PathBuilder Transseptal Guiding Introducer |
Shanghai MicroPort EP MedTech Co., Ltd. |
Tian Xia |
| K212625 |
03/23/2022 |
PathBuilder Transseptal Needle |
Shanghai MicroPort EP MedTech Co., Ltd. |
Tian Xia |
| K210216 |
03/04/2022 |
Disposable Automatically Retractable Insulin Safety Syringe |
Shantou Wealy Medical Instrument CO.,Ltd |
Yuhe Yang |
| K220229 |
03/26/2022 |
Powder Free Nitrile Examination Gloves, Orange |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Wu Zhigang |
| K212945 |
03/01/2022 |
Sterile Disposable Temperature Probe |
Shenzhen Envisen Industry Co., Ltd |
Ailsa Huang |
| K213745 |
03/31/2022 |
Air Compression Therapy Device, model: ST-502 |
Shenzhen Future Electronic Co., Ltd |
Zhao Qihong |
| K212395 |
03/25/2022 |
Nebulizer |
Shenzhen Homed Medical Device Co., Ltd. |
Shi Shengming |
| K213835 |
03/03/2022 |
TENS & EMS Device |
Shenzhen Jian feng Electronic Technology Co. Ltd. |
Feng Wen |
| K213741 |
03/08/2022 |
TENS & EMS DEVICE (Model: FM-B2403A) |
Shenzhen Jianfeng Electronic Technology Co. Ltd. |
Feng Wen |
| K220051 |
03/04/2022 |
TE Air Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Shi Jufang |
| K220242 |
03/25/2022 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Jiang Xiaoyong |
| K214113 |
03/28/2022 |
Hand-held IPL device(JOVS Graphene Hair Removal Device) |
Shenzhen Qianyu Technology Co., Ltd. |
Kunming Lin |
| K213358 |
03/04/2022 |
Surgical Mask |
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd |
Patty Chen |
| K210848 |
03/01/2022 |
Sure-Fine Insulin Syringes |
Shina Med Corporation |
Jeong Ho Ryu |
| K211484 |
03/01/2022 |
DisposableáSterileáSyringeáwitháSafetyáNeedle; DisposableáSterileáSyringeáwitháNeedle; DisposableáSterileáSyringe; DisposableáSafetyáNeedles |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Xiaolei Tian |
| K213965 |
03/18/2022 |
BeautiBond Xtreme |
Shofu Dental Corporation |
Mauro Malzyner |
| K212939 |
03/18/2022 |
Vintage Prime Press |
Shofu Dental Corporation |
Mauro Malzyner |
| K213615 |
03/11/2022 |
Shoulder Innovations Total Shoulder System |
Shoulder Innovations, Inc. |
Don Running |
| K210489 |
03/17/2022 |
SICtapered & SICvantage tapered |
SIC invent AG |
Cretia Arlene McNett |
| K210171 |
03/18/2022 |
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) |
Sichuan YOUKEDE Medical Equipment Co.,Ltd |
Sukey Chia |
| K212379 |
03/02/2022 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
Martina Pfeiff |
| K220450 |
03/07/2022 |
syngo.CT Applications |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K212889 |
03/28/2022 |
Syngo.CT Dual Energy |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K220425 |
03/11/2022 |
MAGNETOM Vida, MAGNETOM Sola |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K212755 |
03/10/2022 |
SIGNUS SACRONAIL« Transsacral Stabilization System |
SIGNUS Medizintechnik GmbH |
Holger Noss |
| K212393 |
03/14/2022 |
OPN NC PTCA Dilatation Catheter |
SIS Medical AG |
Sergej Kammerzell |
| K212940 |
03/04/2022 |
Skanmobile, Skanmobile-Dr |
Skanray Technologies Limited |
Vasundhara R |
| K213373 |
03/10/2022 |
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Smart Glove Corporation Sdn.Bhd. |
Lim Chin Keong |
| K213827 |
03/11/2022 |
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) |
Smith & Nephew, Inc. |
Stephanie Rincones |
| K210923 |
03/02/2022 |
Southern Implants Instrument Trays |
Southern Implants (Pty) Ltd |
Lauranda G Breytenbach |
| K210341 |
03/10/2022 |
One Step Pregnancy Test |
SPD Swiss Precision Diagnostics GmbH |
Joanne Scaife |
| K214071 |
03/10/2022 |
Hexa-Temp |
SPIDENT CO., LTD. |
J.M. Ahn |
| K211880 |
03/11/2022 |
Minuteman G5 MIS Fusion Plate |
Spinal Simplicity LLC |
Adam Rogers |
| K220160 |
03/31/2022 |
PediGuard Threaded |
Spine Guard S.A. |
Stephane Bette |
| K220473 |
03/18/2022 |
CELERITY 20 HP Challenge Pack |
STERIS |
Anthony Piotrkowski |
| K220395 |
03/11/2022 |
EndoGator Endoscopy Irrigation Tubing |
STERIS Corporation |
Carroll Martin |
| K220361 |
03/10/2022 |
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide |
STERIS Corporation |
Jennifer Nalepka |
| K220196 |
03/24/2022 |
Steth IO Spot |
StratoScientific |
Mahesh Mulumudi |
| K211140 |
03/08/2022 |
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Re |
Stryker Sustainability Solutions |
Moira Barton-Varty |
| K211138 |
03/08/2022 |
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), R |
Stryker Sustainability Solutions |
Mia Brown |
| K220213 |
03/30/2022 |
Empulse R90 |
Sunrise Medical (US) LLC |
Devin McElroy |
| K220501 |
03/23/2022 |
Pounce Thrombectomy System |
Surmodics Inc. |
Holly Ramirez |
| K213662 |
03/28/2022 |
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) |
Taishan Weibang Medical Equipment Co., Ltd. |
Shuhui Zhou |
| K220199 |
03/21/2022 |
AFFINITY Proximal Tibia System |
Techfit Digital Surgery INC. |
Leidy Johanna Toro-Gonzalez |
| K212049 |
03/08/2022 |
Oclet TDS 1000 |
TendoNova Corporation |
Mark Samuels |
| K212628 |
03/11/2022 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K220202 |
03/31/2022 |
Uterine ElevatOR PRO with OccludOR Balloon |
The O R Company Pty Ltd |
Nicole Conway |
| K213558 |
03/08/2022 |
IPL Hair Removal Device |
Ulike Co., Ltd |
Lin Xiaoming |
| K211802 |
03/01/2022 |
GoBack Crossing Catheter |
Upstream Peripheral Technologies, Ltd |
Dan Rottenberg |
| K213444 |
03/17/2022 |
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm |
Ureteral Stent Company |
Mike Bunker |
| K211868 |
03/01/2022 |
MYAH |
VISIA imaging S.R.L. |
Alessia Magnanini |
| K213869 |
03/11/2022 |
EmbryoSlide+ ic8 dish |
Vitrolife A/S |
Belinda Dueholm |
| K210151 |
03/01/2022 |
Digimamo D |
VMI Tecnologias LTDA |
Siele Santos |
| K220133 |
03/10/2022 |
Sterilization Wraps |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Bin Dong |
| K210330 |
03/04/2022 |
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant |
WRP Asia Pacific SDN BHD |
Zahari Bin Darus |
| K213703 |
03/04/2022 |
Surgical Gown |
Wujiang Tutaike Textiles & Finishing Co., Ltd. |
Zhang Yanwen |
| K211811 |
03/03/2022 |
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers |
Wuxi Beien Surgery Device Co., Ltd. |
Juan Li |
| K211850 |
03/03/2022 |
Air Compression Leg Massager (model: FE-7204B) |
Xiamen Healthpal Electronic Co.,Ltd |
Henry Zhang |
| K213806 |
03/12/2022 |
Disposable Medical Face Mask |
Xiantao Zhibo Nonwoven Products Co., Ltd |
Fen Peng |
| K213285 |
03/03/2022 |
easy Claire |
Y & J Bio Co., Ltd. |
Chun Young Sam |
| K220206 |
03/24/2022 |
Mobility Scooter |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Leo Zheng |
| K220207 |
03/24/2022 |
Mobility Scooter, Model W3468 |
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
Leo Zheng |
