| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K213295 |
11/17/2022 |
C.C. LIFE 21 |
21 Equipment S.R.L. |
Dolores Moretto |
| K211499 |
01/06/2022 |
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) |
23andMe, Inc. |
Marianna Frendo |
| K222508 |
11/01/2022 |
3MÖ ComplyÖ Hydrogen Peroxide Chemical Indicator 1248 |
3M Company |
Yumi Wackerfuss |
| K203293 |
01/21/2022 |
Abbott Medical Grounding Pad, model RF-DGP-IS |
Abbott Medical |
Jordan Hanson |
| K222109 |
11/17/2022 |
Accure Laser |
Accure Acne, Inc. |
Karl Nicholls |
| K220833 |
11/04/2022 |
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K212990 |
01/07/2022 |
Acumed Ankle Syndesmosis Repair System |
Acumed LLC |
Janki Bhatt |
| K213438 |
01/19/2022 |
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory |
Adaptiiv |
Anastasiia Mereshchuk |
| K221719 |
11/03/2022 |
ABTross ALIF Expandable Cage System |
Aegis Spine, Inc. |
KiHyang Kim |
| K223328 |
11/30/2022 |
Purgo |
AeroClean Technologies, Inc. |
Richard Foster |
| K222363 |
11/28/2022 |
Aevumed PHANTOMÖ-LP Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K221183 |
11/10/2022 |
AEYE-DS |
AEYE Health, Inc. |
Zack Dvey-Aharon |
| K211110 |
01/07/2022 |
Agile Devices Angler Steerable, Deflectable Microcatheter |
Agile Devices, Inc. |
Stephen Tully |
| K211443 |
01/07/2022 |
AIBOLIT 3D+ |
AIbolit Technologies, LLC |
Howard Schrayer |
| K213570 |
01/07/2022 |
Dental Zirconia Ceramic |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Wang Lili |
| K221330 |
11/18/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K220346 |
11/07/2022 |
Lotus Prophy Angle |
AJK Engineering, Inc. |
Ajay Kumar |
| K210564 |
01/07/2022 |
Infrared Thermometer |
Alicn Medical Shenzhen, Inc |
Fang Meisong |
| K212877 |
01/12/2022 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K223009 |
11/27/2022 |
Wireless/Wired X-Ray Flat Panel Detectors |
Allengers Medical Systems Limited |
Sanjeev K. Marjara |
| K222973 |
11/17/2022 |
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interb |
Alphatec Spine Inc. |
Andrew Zhang |
| K222455 |
11/18/2022 |
Calibrate LTX Interbody System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K213523 |
01/28/2022 |
X-CUBE i8, X-CUBE i9 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K223270 |
11/01/2022 |
POSEÖ Health Care Surgical Mask |
America's Supply Chains |
Paul Park |
| K222749 |
11/14/2022 |
High Fluid-Resistant Surgical and Procedure Mask |
AmericaÆs Supply Chains |
Paul Park |
| K220230 |
11/10/2022 |
AMSure Enteral Feeding Pump |
Amsino International Inc. |
Jane Gao |
| K212598 |
01/28/2022 |
iHealth infrared Ear thermometer PT5 |
Andon Health Co., Ltd. |
Liu Yi |
| K222124 |
11/04/2022 |
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
Bingyi Xiang |
| K213325 |
01/28/2022 |
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs |
Anhui Xinyisheng Medical Technology Co., Ltd |
Wei Wei Tang |
| K221608 |
11/22/2022 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether |
AnX Robotica Corp |
Tim Thomas |
| K220421 |
11/04/2022 |
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K213215 |
11/25/2022 |
VSI HoloMedicine |
ApoQlar GmbH |
Liliana Duarte |
| K223164 |
11/04/2022 |
Aquilo Sports CCT1500 System |
Aquilo SPorts LLC |
JP Spence |
| K210101 |
01/26/2022 |
American-Made Surgical Mask |
Armbrust Inc. |
Landon Morales |
| K220663 |
11/22/2022 |
AccuCTP |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K222084 |
11/02/2022 |
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie |
Asahi Polyslider Co., Ltd. |
Yoshitaka Akagi |
| K223293 |
11/18/2022 |
CONTOUR« NEXT GEN Blood Glucose Monitoring System |
Ascensia Diabetes Care US Inc. |
Larnie James |
| K213347 |
01/25/2022 |
ADI Medical Surgical Face Mask |
Asia Dynamics Inc., d/b/a ADI Medical |
Jonathan Zhu |
| K220905 |
11/17/2022 |
xvision Spine System |
Augmedics Ltd. |
Contact Title |
| K221499 |
11/22/2022 |
Minimally Invasive Prostate Surgery Navigation System |
Augment Intelligent Medical System (China) Co., Ltd. |
Chen Lihong |
| K213018 |
11/18/2022 |
Auxilock GFS Mini, GFS II Large, and GFS Ultimate |
Auxein Medical Private Limited |
Rahul Luthra |
| K213108 |
11/04/2022 |
Humerus & Ulna System |
Auxein Medical Private Limited |
Rahul Luthra |
| K222967 |
11/23/2022 |
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K221268 |
11/21/2022 |
SR-1 Skin Treatment System |
AVAVA, Inc |
Jay Bhawalkar |
| K221624 |
11/22/2022 |
Avenda Health AI Prostate Cancer Planning Software |
Avenda Health, Inc. |
Brittany Berry-Pusey |
| K221716 |
11/22/2022 |
CINA |
AVICENNA.AI |
Stephane Berger |
| K212468 |
01/06/2022 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
Thomas Lawson |
| K211210 |
01/27/2022 |
Sterile Auto-Disable Syringes with/without Needle for Single Use |
Azur Medical Company Inc. |
Di Zhao |
| K213673 |
01/21/2022 |
b-ONE MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
Allison Gecik |
| K212842 |
01/18/2022 |
Microvolume Luer Access Device |
B. Braun Medical Inc. |
Kimberly Smith |
| K221815 |
11/23/2022 |
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
Baisheng Medical Co., Ltd. |
Xi Chen |
| K223198 |
11/10/2022 |
BD Intraosseous Vascular Access System EMS Powered Driver (D001003) |
Bard Access Systems |
Nasreen Al-Quaid |
| K220558 |
11/17/2022 |
Blood Administration Sets |
Baxter Healthcare Corporation |
James L. Vangeisen |
| K213639 |
01/24/2022 |
Revaclear 500, Revaclear 400, Revaclear 300 |
Baxter Healthcare Corporation |
Jesse Seidman |
| K223246 |
11/18/2022 |
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense |
Baxter Healthcare Corproration |
Jigar Shah |
| K221225 |
11/10/2022 |
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K211507 |
11/22/2022 |
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) |
Beiang Air Tech LTD. |
Yan Zhang |
| K211752 |
01/21/2022 |
Infrared Thermometer |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K222408 |
11/29/2022 |
Disposable Safety Lancet |
Beijing Ruicheng Medical Supplies Co., Ltd. |
Yuechao Li |
| K212478 |
01/14/2022 |
Dermatological diode laser system |
Beijing Stelle Laser Technology Co., Ltd. |
Zhao Changcheng |
| K213217 |
11/14/2022 |
Disposable hemoclip |
Beijing ZKSK Technology Co.,Ltd |
Ma Li |
| K211419 |
01/10/2022 |
Gingi-Aid Gel |
Belport Company, Inc., Gingi-Pak |
Mohammed Islam |
| K221045 |
11/03/2022 |
Insulin Syringes without needle |
Berpu Medical Technology Co., Ltd |
Buxin Yu |
| K222903 |
11/18/2022 |
Tailored-H Cervical Stand Alone System |
BeSpoke Technologies, LLC |
Daniel Hoehn |
| K221184 |
11/02/2022 |
ORiGO System |
Bien-Air Surgery SA |
Jonas Guerdat |
| K212841 |
01/07/2022 |
Pectus Blu Support Bar System |
Biomet Micofixation |
Mark Wladowski |
| K223199 |
11/15/2022 |
2.1 x 255mm Drill, 22mm Stop |
Biomet Microfixation |
Jay Sharma |
| K220535 |
11/15/2022 |
Cardio10 |
Bionet Co., Ltd. |
Kyungeun Park |
| K222964 |
11/22/2022 |
BioPoly Lesser Toe Hemiarthroplasty Implant |
BioPoly, LLC |
Herb Schwartz |
| K211219 |
01/26/2022 |
LASSOSTAR NAV Circular Mapping Catheter |
Biosense Webster, Inc. |
Michelle Wheeler |
| K211709 |
01/19/2022 |
Biotres |
Biotricity |
Spencer LaDow |
| K213546 |
01/06/2022 |
ExactechGPS Total Shoulder Application, Equinoxe Planning Software |
Blue Ortho |
Matthieu Coic |
| K212991 |
01/21/2022 |
Osteorevive |
Bone Solutions, Inc. |
Drew Diaz |
| K211934 |
11/10/2022 |
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Cath |
Boston Scientific Corporation |
Liz Johnston |
| K213593 |
01/14/2022 |
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD |
Boston Scientific Corporation |
Cassie Clark |
| K213879 |
01/05/2022 |
Self-adhesive Electrode |
Bozhou Rongjian Medical Appliance Co.,Ltd. |
Zhifang Wu |
| K211816 |
11/02/2022 |
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Brightway Holdings Sdn. Bhd. |
G. Baskaran |
| K203773 |
01/14/2022 |
BRM TOOL Screws |
BRM Extremities Srl |
Andrea De Maglio |
| K213344 |
01/05/2022 |
BTL-899A |
BTL Industries Inc. |
David Chmel |
| K222237 |
11/22/2022 |
Cala kIQ |
Cala Health, Inc. |
Danielle McDonnell Boyd |
| K222673 |
11/17/2022 |
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
Rashid Reza Mir Sayah |
| K222915 |
11/15/2022 |
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
Rashid Reza Mir Sayah |
| K213780 |
01/24/2022 |
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 |
Canon Inc. |
Akira Hirai |
| K212333 |
01/24/2022 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K213335 |
01/14/2022 |
Capsule Surveillance System |
Capsule Surveillance Technologies, SAS /Capsule Tech, Inc. |
Peter Kelley |
| K210747 |
01/19/2022 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health |
Sam Surette |
| K211830 |
11/15/2022 |
LifeSPARC System |
CardiacAssist, Inc. |
Megan Walsh |
| K222652 |
11/28/2022 |
Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer |
Cardicare Company, Ltd. |
Ying Hao |
| K211666 |
01/09/2022 |
Powder Free Nitrile Examination Gloves, Blue Chemotest |
Careglove Global SDN. BHD. |
Siti Khatijah Ahmad |
| K213307 |
01/14/2022 |
Eclipse II with Smart Noise Cancellation |
Carestream Health, Inc. |
Gina Maiolo |
| K222009 |
11/22/2022 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
Karen Liu |
| K213211 |
01/27/2022 |
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System |
Carolina Liquid Chemistries, Corp. |
Patricia A Shugart |
| K222317 |
11/10/2022 |
Catalyst EA Convertible Stemmed Shoulder |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K212173 |
01/25/2022 |
HDH Treatment Planning System |
CDB Corporation |
Leah M Lehman |
| K214084 |
01/20/2022 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Lorenzo Bortolotti |
| K222377 |
11/03/2022 |
Led Mask Platinum Md |
CellReturn Co., LTD. |
Ilsoo Kim |
| K221152 |
11/23/2022 |
CuringPen Dental Curing Light |
Changzhou Sifary Medical Technology Co., Ltd. |
Iris Cai |
| K201044 |
01/18/2022 |
CHIRANA Insulin Syringes |
CHIRANA T. Injecta |
Zdenka Klbeckova |
| K220351 |
11/18/2022 |
Polso Watch |
Chronisense Medical, Ltd. |
Bridget Ross |
| K222052 |
11/22/2022 |
VitroPRO |
CIVCO Medical Instruments Co., Inc. |
Jim Leong |
| K220097 |
01/13/2022 |
PRESIDENT The Original |
ColtΦne/Whaledent AG |
Katrin Ader |
| K221593 |
11/17/2022 |
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
ConvaTec, Inc. |
Courtney Smith |
| K220408 |
11/10/2022 |
AVIEW RT ACS |
Coreline Soft Co.,Ltd |
Hyeyi Park |
| K214059 |
01/19/2022 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K221771 |
11/30/2022 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chan |
| K222641 |
11/29/2022 |
SigniaÖ Small Diameter Reloads Including Regular (Round) Tip Version |
Covidien |
Robert Zott |
| K213602 |
01/14/2022 |
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit |
Covidien, llc |
Carol S Ming |
| K201323 |
01/25/2022 |
INNO SLA Submerged Implant System |
Cowellmedi Co., Ltd. |
Minjin Park |
| K220334 |
11/09/2022 |
MONET Anterior Cervical Plate System |
CTL Medical Corporation |
Sean Suh |
| K222550 |
11/01/2022 |
Current Health System |
Current Health Ltd. |
Shyama Ramjagsingh |
| K223110 |
11/03/2022 |
truSculpt iD |
Cutera Inc. |
Julia Brown |
| K210039 |
01/07/2022 |
CORE1 Implant System |
Cybermed Inc. |
Han Seul Kim |
| K212012 |
01/19/2022 |
Follicle Clarity |
Cycle Clarity |
John Schnorr |
| K213692 |
01/26/2022 |
SmoothSkin Pure Mini |
CyDen Limited |
Adam Stephens |
| K223292 |
11/23/2022 |
TempSure System |
Cynosure LLC |
Michael King |
| K213970 |
01/23/2022 |
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply |
Danameco Medical Joint Stock Corporation |
Huynh Thi Li Li |
| K221556 |
11/28/2022 |
T-Line Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K213901 |
01/07/2022 |
CyclopsÖ Anterior Cervical Plate System |
DeGen Medical |
Craig Black |
| K212541 |
01/10/2022 |
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix |
DeltaMed GmbH |
Michael Zimmermann |
| K220042 |
11/17/2022 |
Dentca Base Premium, Dentca Base Hi-Impact |
Dentca, Inc. |
Jason Lee |
| K222918 |
11/25/2022 |
DentCare Aligners |
DentCare Dental Lab Pvt Ltd. |
Abin Johns Raju |
| K222054 |
11/22/2022 |
Denti.AI Auto-Chart |
Denti.AI Technology Inc. |
Lyudmila Tuzova |
| K221094 |
11/16/2022 |
OmniTaper EV Dental Implants, DS Implants abutments with EV connection |
Dentsply Sirona |
Courtney Clark |
| K220841 |
11/16/2022 |
PrimeTaper EV Dental Implants ╪3.0, DS Implants abutments with EV connection (XS) |
Dentsply Sirona |
Courtney Clark |
| K212683 |
01/19/2022 |
GLOBAL ICON Stemless Shoulder System |
DePuy (Ireland) |
Kathy Harris |
| K213781 |
01/18/2022 |
ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP |
DePuy Ireland UC |
Erin Combs |
| K213839 |
01/06/2022 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics Inc. |
Erin Combs |
| K221391 |
11/10/2022 |
WOLF ThrombectomyÖ SmartClaw Catheter |
DeVoro Medical, Inc |
Vanessa Fowler |
| K213401 |
01/31/2022 |
DIAPLUS Universal |
Diadent Group International |
Kab Sun Lee |
| K221471 |
11/22/2022 |
E3 and Profile |
Diagnosys LLC |
Jeffrey Farmer |
| K202755 |
11/05/2022 |
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K222734 |
11/08/2022 |
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing |
Diversatek Healthcare |
Alyssa Roelli |
| K212318 |
01/14/2022 |
IPL Hair Removal |
Dongguan Define Beauty Electronic Technology Co. Ltd |
Shaowu Wang |
| K222477 |
11/18/2022 |
Hair Growth Device |
Dongguan Lescolton Medical Equipment Co., Ltd |
Qixiang Liu |
| K212884 |
01/20/2022 |
Electric breast pump |
Dongguan Rongfeng Medical Co., Ltd. |
Qianqian Yu |
| K223124 |
11/18/2022 |
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG |
DRTECH Corporation |
Ella An |
| K213188 |
01/31/2022 |
Primary Relief |
DyAnsys, Inc. |
Srini Nageshwar |
| K213102 |
01/11/2022 |
ES1 System |
E-Scopics |
Claude Cohen-Bacrie |
| K221833 |
11/07/2022 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module |
Edwards Life Sciences LLC |
Varad Raghuwanshi |
| K223127 |
11/07/2022 |
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable |
Edwards Lifeciences, LLC |
Michelle Ducca |
| K221704 |
11/22/2022 |
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) |
Edwards Lifesciences, LLC |
Michelle Ducca |
| K222496 |
11/18/2022 |
Electromed SmartVest Airway Clearance System |
Electromed, Inc. |
Gregory Spurlock |
| K222395 |
11/02/2022 |
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo |
Ellex Medical Pty Ltd |
Rashmi Pillay |
| K222044 |
11/30/2022 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Lise Terkelsen |
| K213981 |
11/12/2022 |
Nitrile Examination Gloves |
Emerald Glove Manufacturing Sdn Bhd |
Amran A. Aziz |
| K221282 |
11/20/2022 |
Empatica Health Monitoring Platform |
Empatica S.r.l. |
Alberto Poli |
| K212941 |
01/20/2022 |
Porous Patella |
Encore Medical, L.P. dba DJO Surgical |
Michael A Siano |
| K211941 |
01/27/2022 |
9Line |
Energetic Designs, Inc. |
Kathy Fortin |
| K220533 |
11/16/2022 |
Endoscopy Oxygen Mask |
Engineered Medical Systems Inc. |
Tamara Lefevers |
| K222551 |
11/10/2022 |
Humask Pro Vision, Humask Pro Vision 3000 |
Entreprise Premont Inc. |
Charlie Marchand |
| K221744 |
11/15/2022 |
STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device |
Ethicon, Inc. |
Jenny Wang |
| K221552 |
11/08/2022 |
EFAI ChestSuite XR Pneumothorax Assessment System |
Ever Fortune AI Co., Ltd. |
Joseph Chang |
| K222488 |
11/15/2022 |
Everyway Analog OTC TENS |
Everyway Medical Instruments Co., Ltd |
Jimmy Cheng |
| K222198 |
11/09/2022 |
Exo Iris (El2001) |
Exo Imaging Inc. |
Antoanela Gomard |
| K222539 |
11/18/2022 |
Facet Blood Lancets |
Facet Technologies LLC |
James Bonds |
| K223099 |
11/28/2022 |
Facet Manatee Reusable Lancing Base |
Facet Technologies LLC |
James Bonds |
| K221369 |
11/18/2022 |
FBCC Night Guard |
FBCC Inc |
Pablo Osorio |
| K221139 |
11/10/2022 |
Bodygard SFS Surgical Gown Level 4 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri |
Ali Serdar Serteser |
| K212111 |
01/23/2022 |
Myflon Surgical Mask Level 3 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi |
Ali Serdar Serteser |
| K211096 |
01/28/2022 |
Optiflow Oxygen Kit |
Fisher &Paykel Healthcare Ltd. |
Reena Daken |
| K222390 |
11/21/2022 |
Flex-ThreadÖ Ulna Intramedullary Nail System |
Flower Orthopedics Corporation DBA Conventus Flower |
Christina Rovaldi |
| K222061 |
11/10/2022 |
Dental LT Clear V2 Resin |
Formlabs Ohio, Inc. |
Ritika Sharma |
| K212610 |
01/26/2022 |
Surgical Face Mask |
Foshan Nanhai Plus Medical CO LTD |
Suyi Li |
| K222480 |
11/14/2022 |
Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) |
Foshan Nanhai Plus Medical Co., Ltd. |
Eric Li |
| K203072 |
01/19/2022 |
Franz Zirconia Dental Crown |
Franz Biotech Inc. |
Anita Chen |
| K213187 |
01/03/2022 |
Disposable Nitrile Medical Powder-free Glove |
Fujian Chunhui Medical Supply Co., Ltd. |
Jing Cai |
| K221677 |
11/10/2022 |
Synapse 3D Base Tools v6.6 |
FUJIFILM Corporation |
Randy Vader |
| K220957 |
11/10/2022 |
FUJIFILM Endoscope Model EB-710P |
FUJIFILM Corporaton |
Randy Vader |
| K202914 |
01/26/2022 |
SternaFuse Fixation System |
Fusion Innovations, LLC |
Mark Schumacher |
| K222936 |
11/07/2022 |
Humeris« 135 Shoulder System |
FX Shoulder USA, Inc. |
Cory Trier |
| K212954 |
01/10/2022 |
G-Tech Wireless Patch System (WPS) |
G-Tech Medical |
Steve Axelrod |
| K213095 |
01/12/2022 |
andorate Suction Valve, andorate Air/Water Valve |
GA Health Company Limited |
Cindy Ye |
| K223171 |
11/10/2022 |
AquaPulse« Irrigation Tubing |
GA Health Company Limited |
Cindy Ye |
| K213642 |
01/13/2022 |
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert |
GE Healthcare |
Bryan Behn |
| K213668 |
01/20/2022 |
SIGNA Hero |
GE Healthcare (GE Medical Systems, LLC) |
Sandra Westphal |
| K211980 |
01/16/2022 |
SIGNA Prime |
GE Healthcare (Tianjin) Company Limited |
Huande Li |
| K222895 |
11/22/2022 |
DynamicIQ |
GE Medical Systems SCS |
Tong Zhao |
| K223152 |
11/22/2022 |
Vision 2, EVARVision, TrackVision 2, HeartVision 2 |
GE Medical Systems SCS |
Ning Wen |
| K213709 |
01/20/2022 |
SIGNA PET/MR |
GE Medical Systems, LLC |
Brian R Zielski |
| K212797 |
01/06/2022 |
iPrime Viscodelivery System |
Glaukos |
Alex Bhaskarla |
| K222160 |
11/22/2022 |
GUS610 Blood pressure monitor |
Globalcare Medical Technology Co., Ltd. |
Chiara Cavagnolo |
| K213591 |
01/26/2022 |
ANTHEM« Fracture System |
Globus Medical Inc. |
Jennifer Antonacci |
| K213424 |
01/19/2022 |
Jabra Enhance Plus |
GN Hearing A/S |
Lars Hagander |
| K191105 |
01/21/2022 |
e-Throne Folding Wheelchair, Model: ET-12F22 |
Golden Motor Technology Co., Ltd. |
Philip Yao |
| K210198 |
01/07/2022 |
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head |
GPC Medical Limited |
Vikas Narang |
| K223355 |
11/03/2022 |
Tera Harz Clear |
Graphy Inc. |
Moon Soo Part |
| K221539 |
11/09/2022 |
GammaTile |
GT Medical Technologies |
Jessica Newhard |
| K222453 |
11/04/2022 |
Self-adhesive Electrode |
Guangdong Comytens Medical Technology Co., Ltd |
Mr. Deng Jiuzhen |
| K223068 |
11/23/2022 |
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) |
Guangdong Golden Leaves Technology Development Co., LTD |
Wenhong Zhou |
| K222612 |
11/25/2022 |
Powder-Free Latex examination gloves |
Guangdong Kingfa Sci.&Tech. Co., Ltd. |
Xiaoge Yu |
| K212997 |
01/14/2022 |
Surgical Mask |
Guangdong Zhizhen Biological Medical Co., Ltd |
Caiyun Zhou |
| K213082 |
01/28/2022 |
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K222305 |
11/30/2022 |
MissLanÖ Digital Pregnancy Rapid Test |
Guangzhou Decheng Biotechnology Co. Ltd. |
Weifang Liu |
| K213643 |
01/14/2022 |
UltraPrint-Dental Temp C&B UV |
Guangzhou Heygears Imc. Inc |
Lin Liu |
| K212994 |
01/17/2022 |
Medical Face Mask |
Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. |
Hao Zheng |
| K213042 |
11/17/2022 |
Supra Non-Stick Bipolar Forceps |
Guenter Bissinger Medizintechnik GmbH |
Matthias Bissinger |
| K222569 |
11/23/2022 |
Ai Ray Dental X-Ray Device |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K203706 |
01/13/2022 |
Dental Electric Motor |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Jiakang Ning |
| K211358 |
11/21/2022 |
Implanter incl. Accessories |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yang Yunfeng |
| K222304 |
11/08/2022 |
Sonata Transcervical Fibroid Ablation System 2.2 |
Gynesonics, Inc. |
Diane King |
| K212650 |
01/19/2022 |
Celeris, Disposable Sinus Debrider |
Gyrus ACMI, Inc. |
Dolan Mills |
| K213831 |
01/04/2022 |
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle |
Gyrus ACMI, Inc. |
Dolan Mills |
| K220820 |
11/17/2022 |
Parky App |
H2O Bilisim Yazilim |
Yagmur Selin Gulmus-Kolay |
| K221722 |
11/15/2022 |
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) |
Haemonetics Corporation |
Ergang Alexis |
| K222490 |
11/14/2022 |
HBL Blade Assembly |
Hand Biomechanics Lab, Inc |
Dustin Dequine |
| K203272 |
01/31/2022 |
Alltest Pregnancy Rapid Combo Test Cassette |
Hangzhou AllTest Biotech Co., Ltd |
Rosa Wu |
| K222225 |
11/11/2022 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K222741 |
11/07/2022 |
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) |
HDI, Inc. |
Taekyou Kim |
| K213019 |
01/05/2022 |
Vinyl Exam Gloves |
Hebei Astro Medical Supply Co., Ltd |
Ning Zheng |
| K213917 |
11/29/2022 |
QStat Cartridge |
HemoSonics, LLC |
Iskra Mrakovic |
| K220326 |
11/14/2022 |
PosiSep X BAM Hemostat Dressing/Intranasal Splint |
Hemostasis LLC |
Lakshmi Ganesh Bollina |
| K203360 |
01/07/2022 |
EK Implants and Abutments System |
Hiossen, Inc. |
Peter Lee |
| K211436 |
01/27/2022 |
Intermittent Catheter (Not Finalized) |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K212801 |
01/09/2022 |
Powder free nitrile examination glove- black, non sterile |
Hong Seng Gloves Sdn Bhd |
Ho Chia Yao |
| K211716 |
01/07/2022 |
DropSafe Safety Pen Needles |
HTL STREFA SA |
Justyna Zemigala |
| K223003 |
11/18/2022 |
Banded Face Mask |
Hubei Medlink Healthcare Co., Ltd |
Niki Wang |
| K212120 |
01/28/2022 |
Surgical Masks |
Hubei Xinxin Non-woven Co.,Ltd. |
Nicole Jin |
| K221580 |
11/18/2022 |
Single-Use Flexible Cystoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K221581 |
11/18/2022 |
Single-Use Flexible Rhinolaryngoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K222656 |
11/23/2022 |
LDE4 Lancing Device |
i-SENS, Inc. |
H.S. Yoo |
| K211355 |
01/25/2022 |
iCare HOME2 |
Icare Finland Oy |
Hannes Hyv÷nen |
| K220983 |
11/11/2022 |
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System |
ImSonic Medical China, INC. |
Xiaohui Hao |
| K220846 |
11/21/2022 |
CORE-SNARE |
Incore Co., Ltd. |
Jae-Hun Lee |
| K222992 |
11/22/2022 |
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material |
Innovative BioCeramix Inc. |
Quanzu Yang |
| K212166 |
01/07/2022 |
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress |
inomed Medizintechnik GmbH |
Tomasz Moszkowski |
| K212164 |
11/11/2022 |
Mapping Suction Probe |
inomed Medizintechnik GmbH |
Alexander Maier |
| K212533 |
01/28/2022 |
BLX WB ╪5.0 (L18), ╪5.5 and ╪6.5 mm (L14 and L16) Implants |
Institut Straumann AG |
Corinne Arimatea |
| K203768 |
01/27/2022 |
Omnipod 5 ACE Pump (Pod) |
Insulet Corporation |
Alexander Hamad |
| K203772 |
01/27/2022 |
Omnipod 5 SmartBolus Calculator |
Insulet Corporation |
Julie Perkins |
| K203774 |
01/27/2022 |
SmartAdjust technology |
Insulet Corporation |
Alexander Hamad |
| K221811 |
11/21/2022 |
Vista BC Sealer |
Inter-Med, Inc. |
Alex Johnson |
| K223039 |
11/28/2022 |
da Vinci E-200 Electrosurgical Generator |
Intuitive Surgical |
Shamsa Karimi |
| K223080 |
11/22/2022 |
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc |
Connor McCarty |
| K220023 |
01/31/2022 |
8mm Monopolar Curved Scissors |
Intuitive Surgical, Inc. |
Gayle Perry |
| K223132 |
11/09/2022 |
Iridex PASCAL« 532, Iridex PASCAL« 577, Iridex PASCAL« (532nm and 577 nm models) |
Iridex Corporation |
Bill Hyatt |
| K221412 |
11/22/2022 |
ARIX Rib System |
Jeil Medical Corporation |
Sejin Ryu |
| K213044 |
01/21/2022 |
Nitrile Examination Gloves |
Jiangsu Huayuan Medical Technology Co., Ltd. |
Yun Gao |
| K221247 |
11/01/2022 |
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Jiangsu Kangbao Medical Equipment Co., Ltd. |
Rujun Tang |
| K212826 |
01/19/2022 |
Disposable Medical Mask |
Jiangsu Nanfang Medical Co., Ltd. |
Li Xia |
| K212375 |
01/04/2022 |
Disposable Medical Surgical Mask |
Jiangxi Bestgrand Health Technology Co., Ltd. |
Jian long Chen |
| K212913 |
01/14/2022 |
Surgical Face Mask |
Jiangxi Ganlong Pharmaceutical Co.,Ltd. |
Niansheng Liao |
| K222534 |
11/23/2022 |
Nitrile Patient Examination Glove |
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
Zhou Ziyu |
| K211978 |
01/05/2022 |
Jplant |
JJ Medical Co., Ltd. |
Sun Jae Lee |
| K211050 |
11/28/2022 |
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 |
JKH HEALTH CO., LTD. |
Pu Jiang |
| K212115 |
01/05/2022 |
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor |
JOYTECH HEALTHCARE CO.,LTD |
Ren Yunhua |
| K212458 |
01/20/2022 |
Flexible Video-Uretero-Renoscope SSU System |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K222504 |
11/10/2022 |
H1 |
Karl Storz Endoscopy America, Inc. |
Mario Trujillo |
| K212609 |
01/05/2022 |
BHA100 Series Braun Clear Hearing Aid |
Kaz USA, Inc., a Helen of Troy Company |
Matt J. Baun |
| K213380 |
01/11/2022 |
360CAS |
Kico Knee Innovation Company Pty Limited |
Stefanie Auf Der Mauer |
| K220539 |
11/01/2022 |
Klarity SRS Baseplate, Klarity Promise Baseplate |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Lucy Li |
| K203528 |
11/16/2022 |
KNH Surgical Face Mask |
KNH Surgical Face Mask |
Robert Y.L. Pan |
| K214012 |
01/12/2022 |
Straight Arm DDR |
Konica Minolta Healthcare Americas, Inc |
Jan Maniscalco |
| K214030 |
01/21/2022 |
Universal DR 1748 |
Konica Minolta Healthcare Americas, Inc. |
Jan Maniscalco |
| K213908 |
01/31/2022 |
SKR 3000 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K223267 |
11/17/2022 |
SKR 3000 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K211349 |
01/07/2022 |
Selebrek PTCA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co., Ltd. |
Zane Wang |
| K222372 |
11/21/2022 |
Kowa SL-19 |
Kowa Company, Ltd. |
Nariaki Morita |
| K211647 |
01/04/2022 |
HP358EA Electrically Powered Wheelchair |
Kunshan Hi-Fortune Health Products Co., Ltd. |
Jianjiang Fan |
| K212503 |
01/18/2022 |
HP458E Electrically Powered Wheelchair |
Kunshan Hi-Fortune Health Products Co., Ltd. |
Jianjiang Fan |
| K213111 |
01/10/2022 |
MagnetOs granules |
Kuros Biosciences BV |
Sonja van der Meer |
| K212980 |
01/07/2022 |
Tesera-k ALIF System |
Kyocera Medical Technologies, Inc. |
Scott Rucker |
| K220874 |
11/07/2022 |
Smooth Drive contra angle and straight handpieces |
Lares Research |
Bruce Holderbein |
| K212771 |
01/26/2022 |
LightStim Elipsa |
LED Intellectual Properties LLC |
Chase Marchese |
| K211260 |
01/10/2022 |
Sheng Jing Tang Surgical Mask |
Liaoning Shengjingtang Biotechnology Co., Ltd. |
Ke Li |
| K222628 |
11/16/2022 |
Life Spine ALIF Buttress Plate System |
Life Spine, Inc. |
Angela Batker |
| K221946 |
11/22/2022 |
LED Light Therapy Mask (model: MK66R-B) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K223320 |
11/02/2022 |
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Lingshi Hongruida Health Protection Technology Co., Ltd. |
Yin Hongmei |
| K220635 |
11/16/2022 |
Heater-Cooler System 3T |
LivaNova Deutschland GmbH |
Julia E. Leslie |
| K212312 |
01/27/2022 |
RA-T59 Wrist blood pressure monitor |
LotusNine Medical Limited |
Yating Chang |
| K221659 |
11/04/2022 |
Luminopia One |
Luminopia, Inc. |
Scott Xiao |
| K222299 |
11/30/2022 |
Steripath Micro Blood Collection System |
Magnolia Medical Technologies |
Greg Bullington |
| K212569 |
01/12/2022 |
Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner |
Materialise NV |
Simona Beri |
| K213459 |
11/23/2022 |
Glenoid Reconstruction System |
Medacta International S.A. |
Stefano Baj |
| K213281 |
01/05/2022 |
PASS LPÖ Spinal System, CD HorizonÖ Spinal System |
Medicrea International SA |
Karine Trogneux |
| K212005 |
01/12/2022 |
UNiD Spine Analyzer |
MEDICREA International, Inc. |
David Ryan |
| K213833 |
01/14/2022 |
SCOPE BUDDY PLUS Endoscope Flushing Aid |
Medivators Inc |
Mark Arnold |
| K212911 |
11/18/2022 |
Konig Mogen Clamp |
Medline Industries, Inc |
Jennifer Mason |
| K212093 |
01/14/2022 |
Medline Universal Grounding Pad |
Medline Industries, Inc |
Matt Clausen |
| K213068 |
01/03/2022 |
Medline Smoke Evacuation Shroud |
Medline Industries, Inc. |
Matt Clausen |
| K203595 |
01/04/2022 |
DynaFuse Fixation System |
MedShape, Inc. |
Ryan O'Flaherty |
| K222873 |
11/07/2022 |
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system |
Medtronic |
Sarah Meyer |
| K223178 |
11/08/2022 |
SelectSite C304 Deflectable Catheter System, C315 Delivery System |
Medtronic |
Sarah Meyer |
| K201057 |
01/14/2022 |
Bio-Medicus Life Support Catheter and Introducer |
Medtronic Inc. |
Juli Rubin |
| K211269 |
01/07/2022 |
Visualase MRI-Guided Laser Ablation System (SW 3.4) |
Medtronic Navigation, Inc. |
Sharon McDermott |
| K212764 |
11/04/2022 |
Medwell Technology Ltd Syringes, various sizes |
Medwell Technology Ltd |
Andy Song |
| K213696 |
01/21/2022 |
ETHICON Megadyne Electrosurgical Generator |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K220562 |
11/10/2022 |
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment |
MegaGen Implant Co., Ltd. |
Hyo-Eun Lee |
| K223185 |
11/10/2022 |
BreathID« Smart System |
Meridian Bioscience Israel Ltd. |
Raffi Werner |
| K222816 |
11/18/2022 |
Opulent TiNbN Coated Knee |
Meril Healthcare Pvt. Ltd. |
Neelam Desai |
| K212152 |
01/07/2022 |
Prelude IDeal 9F Hydrophilic Sheath Introducer |
Merit Medical Systems |
David Thomas |
| K212936 |
11/21/2022 |
Vision Monitor- MonCvONE |
Metrovision |
Jacques Charlier |
| K212748 |
01/20/2022 |
Disposable Dual Action Tissue Clip |
Micro-Tech (Nanjing) Co., Ltd. |
Cecilia Sun |
| K213816 |
01/05/2022 |
MPO Hip Instruments |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K213817 |
01/05/2022 |
MPO Knee Instruments; MPO PROPHECY Knee Instruments |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K220360 |
11/10/2022 |
Tandry CMF Plate System |
Microware Precision Co., Ltd. |
Harrison Du |
| K213771 |
01/27/2022 |
Merlin Aspiration System |
MIVI Neurovascular, Inc. |
Janel Hurtado |
| K221762 |
11/16/2022 |
BoneMRI v1.4 |
MRlguidance B.V. |
Marijn van Stralen |
| K222518 |
11/17/2022 |
FX Contra |
Nakanishi INC. |
Masaaki Kikuchi |
| K221210 |
11/23/2022 |
PainShield MD PLUS |
NanoVibronix, Inc. |
Hrishikesh Gadagkar |
| K213053 |
01/06/2022 |
Gold Anchor |
Naslund Medical AB |
Tomas NΣslund |
| K221250 |
11/22/2022 |
EasyOne Filter |
NDD Medizintechnik AG |
Andreas Senn |
| K222049 |
11/04/2022 |
Yomi Robotic System |
Neocis Inc. |
Olga Lewis |
| K211613 |
01/19/2022 |
Stern Fix Sternal Stabilization System |
Neos Surgery SL |
Eduard Garcia Puig |
| K220254 |
11/30/2022 |
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software |
Neurosoft Ltd. |
Michael Durdin |
| K221610 |
11/04/2022 |
Nextra CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K221178 |
11/17/2022 |
Disposable Insulin Pen Needle |
Ningbo Medsun Medical Co., Ltd. |
Liu Ping |
| K221518 |
11/03/2022 |
NP Medical nCompass Extension Set with Stabilizing Base |
NP Medical |
Krishna Govindarajan |
| K213942 |
01/11/2022 |
Esteya |
Nucletron B.V. |
Kiran Jose |
| K213915 |
01/12/2022 |
BIB Stent Placement Catheter |
NuMED Inc. |
Nichelle LaFlesh |
| K203177 |
01/02/2022 |
Sterisystem Dry-Base Instrument Tray |
O&M Halyard, Inc |
Steven Dowdley |
| K212612 |
11/15/2022 |
Omnia Medical TiBrid-SC |
Omnia Medical, LLC |
Morgan Hill |
| K222166 |
11/09/2022 |
SOLIX |
Optovue, Inc. |
Robert Lundberg |
| K212648 |
01/28/2022 |
VITROS Immunodiagnostic Products CK-MB Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
| K213572 |
01/18/2022 |
JuniOrtho Plating SystemÖ |
Orthofix Srl |
Gianluca Ricadona |
| K213951 |
01/05/2022 |
FORZA XP Expandable Spacer System |
Orthofix US LLC |
Natalia Volosen |
| K213033 |
01/14/2022 |
iASSIST Knee System |
Orthosoft d/b/a Zimmer CAS |
Paul Hardy |
| K222107 |
11/03/2022 |
Black DiamondÖ POCT Spinal System |
Osseus Fusion Systems |
Jonathan Rosen |
| K212594 |
01/21/2022 |
OSSIOfiber« Staple |
OSSIO Ltd. |
Taly Linder |
| K210360 |
01/27/2022 |
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) |
Osteonic Co., Ltd |
Na Young Kang |
| K222168 |
11/03/2022 |
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler |
Owen Mumford Ltd |
Darren Mansell |
| K212717 |
11/30/2022 |
Paneffort AAMI Level 3 Isolation Gown |
Paneffort, LLC |
Harry Harry |
| K213493 |
01/27/2022 |
Fortilink with TiPlus Technology |
Paradigm Spine |
Jessica Jho |
| K223227 |
11/17/2022 |
MAVENÖ Patient-Specific Instrumentation |
Paragon 28, Inc |
Greg Kowalczyk |
| K210259 |
01/20/2022 |
Parkell Self-Adhesive Cement |
Parkell, Inc |
La-Shaunda Joseph |
| K221478 |
11/01/2022 |
Dolphin Blue Imaging |
Patterson Dental Supply, Inc. |
Erin Daly |
| K212847 |
01/06/2022 |
Penta Glove |
Pentavest Holdings Sdn Bhd |
Teng Boon Joo |
| K220465 |
11/16/2022 |
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 |
PENTAX of America, Inc. |
William Goeller |
| K221822 |
11/04/2022 |
BENCHMARK BMX81 Access System |
Penumbra, Inc |
Sindokht (Sisi) Soltanzadeh |
| K203035 |
11/09/2022 |
Eonis SCID-SMA kit |
PerkinElmer Inc |
Eva Nalian |
| DEN200044 |
11/09/2022 |
Eonis SCID-SMA Kit |
PerkinElmer Inc. |
Casey Fox |
| K221279 |
11/28/2022 |
pNOVUS 21 Microcatheter |
phenox Ltd |
Sarah Cregg |
| K210760 |
01/14/2022 |
Precise Image |
Philips Medical Systems Nederland, B.V. |
Michael Chilbert |
| K222493 |
11/18/2022 |
CODAÖ Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc., |
Alicia Kaufman |
| K203761 |
01/21/2022 |
ParaMotion |
PowerBaseTec GmbH |
Niclas Nachtwey |
| K212772 |
01/15/2022 |
Precision Align |
Precision Align LLC. |
Chris Freeman |
| K213841 |
01/06/2022 |
ENEO TOTALE (Model: ENEOT947) |
Premier North America Inc. |
Ellis Tamari |
| DEN200059 |
01/21/2022 |
POMC/PCSK1/LEPR CDx Panel |
PreventionGenetics, LLC |
Jerry Machado |
| K213427 |
11/22/2022 |
PRIMED Pediatric Facemask |
PRIMED Medical Products Inc. |
Mitra Fard |
| K201256 |
11/04/2022 |
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge |
Procise Diagnostics |
Dan Kiser |
| K212592 |
01/20/2022 |
Gas-Chex Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K211360 |
01/15/2022 |
Disposable Nitrile Powder Free Examination Gloves (Non-sterile) |
Pt. Universal Gloves |
Sutopo Sutopo |
| K191356 |
01/11/2022 |
i3 Foldable Mobility Scooter |
PUC Perfect Union Co., LTD. |
Anita Chen |
| K222208 |
11/17/2022 |
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D |
Qingdao Hisense Medical Equipment Co., Ltd |
Lu Zhonghao |
| K222132 |
11/08/2022 |
Hisense LCD monitor HMD2G21S, HMD3G21S |
Qingdao Hisense Medical Equipment Co., Ltd |
Lu Zhonghao |
| K222067 |
11/10/2022 |
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
Quanta Dialysis Technologies Ltd |
Sam Drew |
| K213737 |
01/14/2022 |
Quantib ND |
Quantib B.V. |
Floor van Leeuwen |
| K202094 |
01/11/2022 |
Cardiovascular Suite 4.2.1 |
Quipu S.R.L |
Vincenzo Gemignani |
| K212341 |
01/28/2022 |
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with |
Qura S.r.l. |
Raffaella Tommasini |
| K212688 |
01/10/2022 |
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger |
Qura S.r.l. |
Raffaella Tommasini |
| K213294 |
11/10/2022 |
Dermal Cooling System |
R2 Technologies, Inc. |
Ragan Reppond |
| K222476 |
11/17/2022 |
OmegaAI Image Viewer |
RamSoft Inc. |
Deeksha Shukla |
| K220489 |
11/07/2022 |
Durex Patronus CloseFit, Durex Patronus Regular |
RB Health (US) LLC |
Kaitlyn Chan |
| K211628 |
01/31/2022 |
MIS Precision Chevron Bunion System |
RELJA Innovations, LLC |
David Pancratz |
| K211589 |
01/27/2022 |
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger |
Remington Medical, Inc. |
Caitlin Senter |
| K223257 |
11/21/2022 |
Miro3D Wound Matrix |
Reprise Biomedical |
Carrie Powers |
| K211789 |
01/04/2022 |
restor3d Pin Implants |
restor3d |
Lexi Lewis |
| K221082 |
11/30/2022 |
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves û Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl |
Rhino Health Inc. |
Mark Lee |
| K212868 |
01/26/2022 |
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT |
Rocamed SAM |
Tahiana Rasolofoniaina |
| K221007 |
11/04/2022 |
cobas HCV |
Roche Molecular Systems, Inc. |
Ashley Malich |
| K213093 |
01/28/2022 |
STEP-1 PumEtch |
Rounding Third LLC |
Thomas Macari |
| K222898 |
11/07/2022 |
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves |
SafeSource Direct, LLC |
Justin Hollingsworth |
| K222800 |
11/07/2022 |
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) |
Sanhe Laserconn Tech Co., Ltd. |
Xia Aijiang |
| K213343 |
01/21/2022 |
Saremco Print CROWNTEC |
Saremco Dental AG |
Franca Schmid |
| K222732 |
11/07/2022 |
WaveForm A Interbody System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K210623 |
11/18/2022 |
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
Sebia |
Karen Anderson |
| K222951 |
11/21/2022 |
SM-V |
SEDECAL SA |
M¬ Luisa G≤mez de Agⁿero |
| K220302 |
11/16/2022 |
Disposable surgical face mask |
Shandong Aida Medical Products Co., Ltd |
Wang Bing |
| K213168 |
01/11/2022 |
Medical Examination Gloves |
Shandong Huiwosheng Health Technology Co.,Ltd |
Haitao Wu |
| K222472 |
11/30/2022 |
Lancing System, Sterile Lancet for Single Use, Lancing Device |
Shandong Lianfa Medical Plastic Products Co. Ltd. |
Charles Shen |
| K211482 |
01/24/2022 |
Disposable Syringe with Needle |
Shandong Qinkai Medical Industry Co., Ltd. |
Ou Kai Jiang |
| K222162 |
11/09/2022 |
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) |
Shanghai AnQing Medical Instrument Co., Ltd |
Shuwen Fan |
| K203395 |
01/28/2022 |
Platform treatment system |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K222540 |
11/14/2022 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K222452 |
11/23/2022 |
Disposable Automatically Retractable Safety Syringes (with detachable needle) |
Shantou Wealy Medical Instrument CO.,Ltd. |
Yanjun Zhu |
| K213142 |
01/28/2022 |
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution |
Shen Wei USA Inc. |
Cheryl Reep |
| K212910 |
11/17/2022 |
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece |
Shenzhen Carejoy Technology Co., Ltd. |
Wei Hui |
| K213447 |
01/19/2022 |
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. |
Shenzhen CosBeauty Technology Co., Ltd. |
Ares Zou |
| K222754 |
11/09/2022 |
ViewMate Multi Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Jin Jiahong |
| K211632 |
01/14/2022 |
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) |
Shenzhen Narig Bio-Medical Technology Co., Ltd. |
Fei Han |
| K222598 |
11/17/2022 |
IPL Hair Removal Device |
Shenzhen Noble Smart Manufacturing Tech Co. Ltd |
Guo Yi |
| K211940 |
01/07/2022 |
Fetal Doppler |
Shenzhen Taikang Medical Equipment Co., Ltd. |
Shigui Du |
| K203812 |
11/08/2022 |
Oxyfit Pulse Oximeter |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K213317 |
01/28/2022 |
ShinEvac Smoke Evacuation Pencil |
Shining World Health Care Co., Ltd. |
Anita Chen |
| K201460 |
11/23/2022 |
Closed System Transfer Device |
Shinva Ande Healthcare Apparatus Co., Ltd. |
XiaoLei Tian |
| K211003 |
01/19/2022 |
SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove |
Showa Best Glove, Inc. |
Jeffrey Richardson |
| K221530 |
11/22/2022 |
ANNE Pediatric |
Sibel Inc. |
Sarah Coughlin |
| K221075 |
11/21/2022 |
Infusion Sets for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221069 |
11/21/2022 |
Infusion Sets for Single Use with Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221078 |
11/21/2022 |
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221281 |
11/17/2022 |
Multitom Rax |
Siemens Medical Solutions |
Denise Adams |
| K222428 |
11/14/2022 |
Syngo Dynamics (Version VA40F) |
Siemens Medical Solutions USA, Inc. |
Jiayan Liu |
| K203260 |
01/28/2022 |
syngo.CT Brain Hemorrhage |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K214019 |
01/20/2022 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K211742 |
01/07/2022 |
SignaSure Dual Mobility System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K223062 |
11/04/2022 |
World Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K220658 |
11/18/2022 |
COSY Cervicothoracic Occipital Rod-Screw System |
SIGNUS Medizintechnik GmbH |
Holger Noss |
| K212373 |
01/27/2022 |
Sim&Size |
Sim&Cure |
Caroline Oziel |
| K222189 |
11/18/2022 |
SiOxD Wound Matrix |
SiOxMed, LLC. |
Mitch Dellinger |
| K211864 |
01/21/2022 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Siyang Jaysun Medtech Co., Ltd. |
Chen Fang |
| K213895 |
01/13/2022 |
Distal Humerus Plating System |
Skeletal Dynamics, Inc. |
Alexandra Rodriguez |
| K211274 |
01/10/2022 |
iQ 2 Nasal Mask, Phantom 2 Nasal Mask |
Sleepnet Corporation |
Jennifer Kennedy |
| K213943 |
11/29/2022 |
SmartSurgN Visualization System |
SmartSurgN Incorporated |
Cathy Mantor |
| K223041 |
11/22/2022 |
Renasys Edge (66803126) |
Smith & Nephew Medical Limited |
Zoe Smith |
| K202783 |
01/14/2022 |
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing |
Smith & Nephew Medical Limited |
Steeve Lamvohee |
| K211330 |
01/19/2022 |
R3 Large Head Liners |
Smith & Nephew, Inc. |
Kayla Franklin |
| K210980 |
11/14/2022 |
Smith & Nephew Intramedullary Nail Systems |
Smith & Nephew, Inc. |
Leah Hawkins |
| K211318 |
01/05/2022 |
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs |
Smith Nephew Medical Limited |
Steeve Lamvohee |
| K222475 |
11/10/2022 |
SNOR LOCK |
Solbaro Co., Ltd |
Donghoon Kim |
| K220466 |
11/03/2022 |
ibiomedi Electronic Stethoscope ES-2020 |
Sound Land Corp. |
Chi-Hsun Hung |
| K222497 |
11/09/2022 |
Zaga Zygomatic System |
Southern Implants (Pty) Ltd |
Leith C. Cumming |
| K212317 |
11/07/2022 |
Eclipse MINI Model 98900 |
Spacelabs Healthcare Ltd. |
Roger Moldon |
| K211954 |
11/10/2022 |
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid |
Spes Medica SRL |
Giorgio Facco |
| K213470 |
01/21/2022 |
PERLA« TL Posterior Osteosynthesis System |
Spineart |
Franck Pennesi |
| K212358 |
01/10/2022 |
Romero Cervical Cage |
SpineUp Inc. |
Philippe Laurito |
| K221578 |
11/14/2022 |
Hexanium ACIF |
SpineVision, S.A.S. |
Quang Tran |
| K221678 |
11/10/2022 |
SprintRay High Impact Denture Base |
SprintRay Inc. |
Sara Moghtadernejad |
| K222701 |
11/18/2022 |
MANTA Laser |
SQUALUS MED Ltd. |
Gil Shapira |
| K221165 |
11/20/2022 |
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl |
Sri Trang Gloves (Thailand) Public Company Limited |
Jordan Smith |
| K213412 |
01/21/2022 |
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM |
STERIS Corparation |
Jennifer Nalepka |
| K213262 |
01/07/2022 |
CELERITY HP Chemical Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K212576 |
01/19/2022 |
MDx-Chex for BCID2 |
Streck, Inc |
Deborah S. Kipp |
| K213859 |
01/13/2022 |
Stronghold Group Nitrile Examination Glove, Powder Free |
Stronghold Group LLC |
David Henderson |
| K213199 |
01/11/2022 |
Asnis« III Cannulated Screw System and Asnis« PRO Cannulated Screw System |
Stryker GmbH |
Danielle Jannuzzi Madureira |
| K222309 |
11/15/2022 |
Gamma4 System |
Stryker GMBH |
Cindy Leon |
| K212581 |
01/19/2022 |
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System |
Stryker GmbH |
Keith Neligan |
| K221855 |
11/09/2022 |
Universal CMF System |
Stryker Leibinger GmbH & Co. KG |
Amelia Kesti |
| K220371 |
11/02/2022 |
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) |
Summit Glove, Inc |
James Hull |
| DEN210015 |
01/07/2022 |
Sunrise Sleep Disorder Diagnostic Aid |
Sunrise |
Francois Naye |
| K211254 |
01/14/2022 |
ARAI Surgical Navigation System |
Surgalign Spine Technologies |
Cristian Luciano |
| K223032 |
11/21/2022 |
SIS System (Version 5.6.0) |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K211361 |
01/13/2022 |
3N Contact Lenses Adjunct Cleaner |
Suzhou 3N Biological Technology Co., Ltd |
Yang Bai |
| K222611 |
11/28/2022 |
Male Latex Condoms |
Suzhou Colour-way New Material Co., Ltd. |
Yongping Xu |
| K212591 |
01/11/2022 |
Disposable Surgical Gown |
Suzhou JaneE Medical Technology Co., Ltd |
Chen Ke |
| K222258 |
11/01/2022 |
Combined High Frequency X-ray Source |
Suzhou Powersite Electric Co., Ltd. |
Xinyue Lu |
| K214090 |
11/01/2022 |
Back 3 COLOR |
SWIMS America Corp |
Matthieu Commeau |
| K212943 |
01/28/2022 |
SyntheCel Dura Repair |
Synthes (USA) products, LLC |
Doug Steinberger |
| K210346 |
11/08/2022 |
Sysmex XW-100 Automated Hematology Analyzer |
Sysmex America, INC. |
Sharita Brooks |
| K212700 |
11/15/2022 |
Dyflex-II |
Taeyeon Medical Co., Ltd. |
Sin-Ae Kang |
| K202994 |
01/04/2022 |
InnoClip Disposable Clip Applier, InnoClip Clip Applier |
Taiwan Surgical Corporation |
Ken Chen |
| K211851 |
01/11/2022 |
Ora-Aid |
TBM Corporation |
Jaewoong Jung |
| K220794 |
11/10/2022 |
10PL |
Tentech Co. Ltd. |
Lee Dong Gun |
| K213075 |
01/20/2022 |
Goody Gloves, Wincare, TBG Gloves |
Thai Rubber Gloves Co., Ltd. |
Chalongkwan Wongsasuthikul |
| K222175 |
11/15/2022 |
Bloomi Delight Oil-Based Personal Lubricant |
The Bloomi Inc.. |
Rebecca Story |
| K212505 |
01/10/2022 |
DUMI ManipulatOR |
The O R Company Pty Ltd |
Amesha Silva |
| K222055 |
11/15/2022 |
Disposable Sterile Lancet |
Tianjin Rilifine Medical Device Co., Ltd. |
Qiusheng Jiang |
| K222246 |
11/21/2022 |
Disposable Sterile Lancet |
Tianjin Rilifine Medical Device Co., Ltd. |
Qiusheng Jiang |
| K211135 |
01/06/2022 |
Enlight 2100 |
Timpel S.A. |
Rafael Holzhacker |
| K221086 |
11/04/2022 |
CryoRobot Select System |
TMRW Life Sciences, Inc. |
Christina Miracle |
| K211265 |
11/17/2022 |
TFX-LT2000 Therapy Light |
ToeFX, Inc. |
Monika Yazdanian |
| K213544 |
01/06/2022 |
TOMTEC-ARENA |
TOMTEC Imaging Systems GmbH |
Marc Bergenthal |
| K222535 |
11/18/2022 |
OCS Lung Donor Flush Set |
TransMedics, Inc. |
Miriam Provost |
| K214106 |
01/28/2022 |
QuikPass Catheter |
Traverse Vascular, Inc. |
Greg Geissinger |
| K222645 |
11/21/2022 |
Treace Medical Concepts (TMC) Implant Fixation System |
Treace Medical Concepts |
Brittany Grochala |
| K222564 |
11/15/2022 |
Treace Medical Concepts (TMC) Hammertoe Fixation System |
Treace Medical Concepts, Inc. |
Kristina Hall |
| K213080 |
01/04/2022 |
T-Edge 10, T-Edge 11 |
Tuttnauer Ltd. |
Robert Basile |
| K223274 |
11/28/2022 |
Momentum« MIS Posterior Spinal Fixation System |
Ulrich Medical USA |
Hans Stover |
| K222463 |
11/23/2022 |
EchoGo Heart Failure |
Ultromics Limited |
Jaco Jacobs |
| K213216 |
01/18/2022 |
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens |
Unicon Optical Co., Ltd |
Nick Liao |
| K221675 |
11/04/2022 |
United U2 femoral head, 22mm delta ceramic head |
United Orthopedic Corporation |
Lois Ho |
| K212736 |
11/22/2022 |
Canady Flex RoboWrist |
US Medical Innovations, LLC |
Jerome Canady |
| K213227 |
01/19/2022 |
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) |
Uweport LLC. |
Mike Wang |
| K213880 |
01/07/2022 |
Custom Stable Rigid Gas Permeable Scleral Contact Lens |
Valley Contax, Inc. |
Josh Adams |
| K213927 |
01/14/2022 |
Respiratory Gating for Scanners v2.0 |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K211149 |
01/05/2022 |
Urethral Warming Catheter Kit |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K222679 |
11/07/2022 |
Vericor Support Catheter |
VascuPatent Medical (Shenzhen) Co. Ltd. |
Heather Li |
| K213308 |
01/12/2022 |
Venus BlissMAX |
Venus Concept USA Inc. |
Nadav Reuben |
| K222639 |
11/04/2022 |
VHA Radiotherapy Bolus |
VHA DEAN |
Beth Ripley |
| K221558 |
11/15/2022 |
ALPHALOK Plating System |
Vilex LLC |
Brock Johnson |
| K212938 |
01/26/2022 |
Vitalograph Model 6000 Alpha |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K222667 |
11/10/2022 |
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
Vivachek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| K221655 |
11/14/2022 |
Multiflex Steerable Sheath |
VizaraMed, Inc. |
Jack P Douglas |
| K220263 |
11/03/2022 |
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers |
Vortex Surgical Inc |
Andrew Ritts |
| K220630 |
11/28/2022 |
TorchTM Software |
Voximetry, Incorporated |
Sue Wallace |
| K210830 |
01/03/2022 |
VUZE System |
VUZE Medical Ltd. |
David Tolkowsky |
| K221162 |
11/04/2022 |
UniVy OsteoVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K211814 |
01/14/2022 |
Wellead Endoscopic Seal |
Well Lead Medical CO., LTD. |
Caroline Gong |
| K222697 |
11/04/2022 |
Disposable Medical Face Mask (DF3-001) |
Wellmed Dental Medical Supply Co., Ltd. |
Tang Renxian |
| K222420 |
11/21/2022 |
Disposable Blood Pressure Cuff |
Wenzhou Xikang Medical Instruments Co., Ltd. |
Wang Tiance |
| K212299 |
01/04/2022 |
Medical Surgical Mask |
Wepon Medical Technology Co., Ltd. |
Yongxian Sun |
| K213356 |
01/20/2022 |
Entuit PEG, Entuit PEGJ |
Wilson-Cook Medical, Inc. |
Tiffanny A. Thomas |
| K210466 |
01/14/2022 |
Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
Haoyuan He |
| K210810 |
01/23/2022 |
Steiking Packaging for Medical Devices |
Wipak OY |
Mira Santala |
| K221123 |
11/22/2022 |
WISE Cortical Strip (WCS) |
WISE S.r.l. |
Luca Ravagnan |
| K213489 |
01/27/2022 |
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate |
WishBone Medical, Inc. |
Ramakrishna Bajaj |
| K212127 |
01/07/2022 |
Picocaremajesty |
Won Tech Co., Ltd. |
Hyun Sik Yoon |
| K213342 |
01/05/2022 |
PRO-DENSE LoVisc Bone Graft Substitute |
Wright Medical Technology, Inc. |
Leslie Fitch |
| K203161 |
01/20/2022 |
Surgical Face Mask |
Wuhan Raytex Protection CO., LTD |
Maggie Yao |
| K212357 |
01/20/2022 |
Surgical isolation gown |
Wuhan Zonsen Medical Products Co., Ltd |
Cynthia Ye |
| K210679 |
01/18/2022 |
Medical Face Mask |
Wuxi Yushou Medical Appliances Co.,Ltd. |
Xiaoling Dai |
| K212713 |
01/18/2022 |
Air compression leg massager HY-1117A |
Xiamen High Top Electronic Technology Co., Ltd. |
Liangsan Zhao |
| K212812 |
11/16/2022 |
Surgical Gown |
Xianning Marveldas Protective Articles CO.,Ltd. |
Zhuxiao Kang |
| K212718 |
01/12/2022 |
Surgical gowns |
Xiantao Dingcheng Non-Woven Product Co., Ltd |
Cheng Qin |
| K222529 |
11/14/2022 |
Surgical Face Mask |
Xiantao Rayxin Medical Products Co., Ltd. |
Maggie Dai |
| K212735 |
01/11/2022 |
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) |
Xingyu Medical Tech Co., Ltd. |
Cathrine Luan |
| K213920 |
01/16/2022 |
Kangbeier Surgical Mask (Model: KBR-1001) |
Xinxiang Kangbeier Medical Technology Co., Ltd. |
Shaoju Tian |
| K222364 |
11/16/2022 |
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) |
Xtrallux, LLC |
Carlos Pi±a |
| K210463 |
01/23/2022 |
Thermoplastic Elastomer (TPE) Hybrid Examination Glove |
Xuzhou Full Sun Medical Products Ltd. |
Hsun-Hui Huang |
| K211333 |
01/20/2022 |
KIDNEY ASSIST-transport |
XVIVO Perfusion AB |
Arjan van der Plaats |
| K223278 |
11/17/2022 |
easy Claire |
Y&J BIO Co., Ltd. |
Youngsam Chun |
| K222980 |
11/21/2022 |
Pentax Medical Valve Set |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K211532 |
01/19/2022 |
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 |
Yibin Junxin Electronics Technology Co., Ltd. |
Guan Chaoze |
| K222520 |
11/14/2022 |
Zirconia Block |
Yilink (Tianjin) Biotechnology Co., Ltd |
Yaqiong Zhu |
| K213475 |
01/27/2022 |
Elevo Snoring Intervention Set |
Zelegent, Inc. |
David C. Humbert |
| K213391 |
01/11/2022 |
High Retention Attachment System |
Zest Anchors, LLC |
Mark Stavro |
| K220739 |
11/17/2022 |
Disposable Urine Collection Tube |
Zhejiang Gongdong Medical Technology Co., Ltd. |
Handson Wei |
| K212854 |
01/10/2022 |
Powered Wheelchair |
Zhejiang Qianxi Vehicle Co., Ltd. |
Ada Zhang |
| K211833 |
01/16/2022 |
Disposable Medical Face Mask |
Zhejiang The Purples Protective Products Co.,Ltd |
Lihui Jiang |
| K221479 |
11/17/2022 |
Persona Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
| K213720 |
01/07/2022 |
Vital Navigation System |
ZimVie (Zimmer Biomet Spine, Inc.) |
Hanna Aucoin |
