Search FDA 510(k) Devices

5,430 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
1321–1344 of 3,023
Cleared Aug 05, 2021
Biomet Microfixation OmniMax MMF System
K202969 · JEY
Biomet Microfixation
Dental · 309d
Cleared Aug 05, 2021
NeuroSENSE Monitoring System, Model NS-901
K202621 · OLW
Neurowave Systems, Inc.
Anesthesiology · 329d
Cleared Aug 05, 2021
ARK Lacosamide Assay
K201089 · NWM
ARK Diagnostics, Inc.
Toxicology · 469d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 486d
Cleared Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K212056 · LNH
Canon Medical Systems Corporation
Radiology · 34d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · LFL
Olympus Medical Systems Corporation
General & Plastic Surgery · 51d
Cleared Aug 04, 2021
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
K211714 · LZA
Hengchang (Dongying) Medical...
General Hospital · 62d
Cleared Aug 04, 2021
Tecomet Global Unite Short Stem Instrumentation
K211553 · PHX
Symmetry Medical Manufacturing Inc....
Orthopedic · 77d
Cleared Aug 04, 2021
Alpha Vent PEEK Suture Anchor
K211502 · MBI
Stryker Endoscopy
Orthopedic · 82d
Cleared Aug 04, 2021
PrevisEA Device
K211068 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 04, 2021
Tigon Medical Button System
K211049 · MBI
Tigon Medical
Orthopedic · 118d
Cleared Aug 04, 2021
V12 PRO
K210913 · IRP
Slk Medical GmbH
Physical Medicine · 128d
Cleared Aug 04, 2021
Disposable Surgical Face Mask
K210643 · FXX
Shandong Zhushi Pharmaceutical Group...
General Hospital · 154d
Cleared Aug 04, 2021
DESS Dental Smart Solutions
K203464 · NHA
Terrats Medical SL
Dental · 253d
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine...
K203246 · LCX
Atlas Link Technology Co., Ltd.
Chemistry · 273d
Cleared Aug 03, 2021
Remex KA6
K212144 · IZL
Remedi Co., Ltd.
Radiology · 25d
Cleared Aug 03, 2021
Surgical Face Mask
K211897 · FXX
Zhejiang Hongyu Medicali Commodity...
General Hospital · 43d
Cleared Aug 03, 2021
Venclose digiRF Generator with Maven Catheter, Venclose Maven System,...
K211806 · GEI
Venclose, Inc.
General & Plastic Surgery · 53d
Cleared Aug 03, 2021
Polychloroprene Powder Free Examination Glove Tested for Use with...
K211758 · OPC
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 03, 2021
Cannulated Fasteners and Nuts
K211290 · HWC
OsteoCentric Technologies
Orthopedic · 97d
Cleared Aug 03, 2021
Minitube Dentasleeve Protective Barrier Sleeves
K211026 · PEM
Minitube AB
Dental · 119d
Cleared Aug 03, 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content...
K210724 · KGO
Careplus (M) Sdn Bhd
General Hospital · 146d
Cleared Aug 03, 2021
Resection Electrodes with HF cable
K210651 · FAS
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 152d
Cleared Aug 03, 2021
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
K201246 · LIT
Qualimed USA, LLC
Cardiovascular · 452d