Search FDA 510(k) Devices

5,426 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
1273–1296 of 3,023
Cleared Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · DJG
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 422d
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha...
K212204 · QGN
Cd Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 11, 2021
Z-LINKPC System
K211993 · NKG
Zavation Medical Products, LLC
Orthopedic · 44d
Cleared Aug 11, 2021
QUANTUM® Patient Specific Instrumentation (PSI) System
K211883 · HSN
In2bones Sas
Orthopedic · 51d
Cleared Aug 11, 2021
Surgical mask
K211552 · FXX
Shandong Shengquan New Materials Co.,...
General Hospital · 84d
Cleared Aug 11, 2021
Medical Face Mask
K211353 · FXX
Shenzhen Lyttop Healthcare Limited
General Hospital · 100d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 120d
Cleared Aug 11, 2021
Solo, Swing Maxi
K210759 · HGX
Medela, LLC
Obstetrics & Gynecology · 149d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · NBW
Ascensia Diabetes Care
Chemistry · 156d
Cleared Aug 11, 2021
Sensatronic Reusable Temperature Probes
K203643 · FLL
Sensatronic GmbH
General Hospital · 240d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Aug 11, 2021
Disposable Face Mask
K203152 · FXX
Chaozhou Cecilia Technology Co., Ltd.
General Hospital · 293d
Cleared Aug 11, 2021
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis...
K202536 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 344d
Cleared Aug 10, 2021
PSX Interbody System
K211873 · MAX
Alphatec Spine, Inc.
Orthopedic · 54d
Cleared Aug 10, 2021
Biodentine XP 500, Biodentine XP 200
K211799 · KIF
Septodont
Dental · 61d
Cleared Aug 10, 2021
Ponto 5 Mini
K211640 · LXB
Oticon Medical AB
Ear, Nose, Throat · 75d
Cleared Aug 10, 2021
KHEIRON Spinal Fixation System
K211414 · NKB
S.M.A.I.O
Orthopedic · 96d
Cleared Aug 10, 2021
EAGLE EDGE AXR90 and AXR120
K210820 · OAS
Alliage S/A Industrias Medico...
Radiology · 144d
Cleared Aug 10, 2021
Nitrile Patient Examination Glove
K210730 · LZA
American Performance Polymers, LLC
General Hospital · 152d
Cleared Aug 10, 2021
sOLVe Tube
K201026 · CBI
Hytek Medical, Inc.
Anesthesiology · 477d
Cleared Aug 09, 2021
Edma Synthetic Nitrile Examination Gloves
K211540 · LZA
Edma Group, LLC
General Hospital · 82d
Cleared Aug 09, 2021
X-CUBE 90
K211300 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 09, 2021
X-CUBE 70
K211299 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
K211030 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 125d