FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
17209–17232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · LYZ
Shandong Jieshi Medical Products Co.,...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210780 · LYZ
Shandong Shangwei Medical Products...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 59d
Cleared May 14, 2021
MicroFrance Monopolar and Bipolar Electrosurgical Instruments
K210942 · GEI
Integra Microfrance
General & Plastic Surgery · 45d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100 · DRA
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared May 14, 2021
NPseal
K211130 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 28d
Cleared May 13, 2021
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron...
K200555 · EMA
Prevest Denpro Limited
Dental · 436d
Cleared May 13, 2021
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High...
K202697 · FXX
United Sewing Automation, Inc.
General Hospital · 239d
Cleared May 13, 2021
LinkSymphoKnee System
K202924 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 226d
Cleared May 13, 2021
CryoVIVE
K203481 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 167d
Cleared May 13, 2021
Tablet Application
K203566 · ODA
Smith & Nephew
General & Plastic Surgery · 157d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369 · LZA
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 13, 2021
HS40 Diagnostic Ultrasound System
K210426 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d
Cleared May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...
K210485 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 83d
Cleared May 13, 2021
Disposable Face Mask
K210815 · FXX
Biobase Scientific (Shandong) Co., Ltd.
General Hospital · 56d
Cleared May 13, 2021
Reliance Spinal Screw System
K210874 · NKB
Reliance Medical Systems, LLC
Orthopedic · 50d
Cleared May 13, 2021
Prelivia
K210979 · IPF
Rehabtronics, Inc.
Physical Medicine · 42d
Cleared May 13, 2021
GMK Spherika Femurs and Fixed Tibial Trays Plus
K211004 · JWH
Medacta International S.A.
Orthopedic · 41d
Cleared May 13, 2021
A1AT Genotyping Test
K211115 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 29d
Cleared May 13, 2021
SIGNA 7.0T
K211118 · LNH
Ge Medical Systems, LLC
Radiology · 28d
Cleared May 12, 2021
NextAR RSA Platform
K210153 · SBF
Medacta International S.A.
Orthopedic · 111d
Cleared May 12, 2021
Automatic Arm Electronic Blood Pressure Monitor
K210435 · DXN
Shenzhen Lepu Intelligent Medical...
Cardiovascular · 89d
Cleared May 12, 2021
NuVasive MOD-EX XLIF Interbody System
K210439 · MAX
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared May 12, 2021
Symbia VA10A Family
K210557 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 76d