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
18145–18168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2021
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
K203153 · NKB
Globus Medical, Inc.
Orthopedic · 89d
Cleared Jan 19, 2021
SnugFit All-Suture Anchor
K203485 · MBI
Medacta International S.A.
Orthopedic · 53d
Cleared Jan 19, 2021
IntraSight Mobile
K203719 · IYO
Volcano Corporation
Cardiovascular · 29d
Cleared Jan 19, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K203726 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Jan 17, 2021
Galapogos
K200565 · BZD
ResMed Corp
Anesthesiology · 319d
Cleared Jan 17, 2021
Nanum Syringe
K201930 · FMF
Nanum Company Co., Ltd.
General & Plastic Surgery · 191d
Cleared Jan 15, 2021
uAI EasyTriage-Rib
K193271 · QFM
Shanghai United Imaging Intelligence...
Radiology · 416d
Cleared Jan 15, 2021
EBERLE Shaver System C3 and Accessories
K193608 · HRX
Eberle GmbH & Co. KG
Orthopedic · 386d
Cleared Jan 15, 2021
NeVa PV Thrombectomy Device
K201085 · QEW
Vesalio
Cardiovascular · 267d
Cleared Jan 15, 2021
Infrared Thermometer
K201579 · FLL
Shenzhen Xunwei Industrial Co., Ltd.
General Hospital · 218d
Cleared Jan 15, 2021
Non-contact Electronic Forehead Infrared Thermometer
K201582 · FLL
Zhongshan Jinli Electronic Weighing?...
General Hospital · 218d
Cleared Jan 15, 2021
VMCore Biopsy Needle
K201650 · KNW
Uro-1, Inc.
Gastroenterology & Urology · 211d
Cleared Jan 15, 2021
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For...
K201897 · FGB
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 191d
Cleared Jan 15, 2021
Medical Protective Mask
K202107 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 170d
Cleared Jan 15, 2021
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
K202141 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 168d
Cleared Jan 15, 2021
Gymform Total ABS
K202653 · NGX
Well Brain International , Ltd.
Physical Medicine · 123d
Cleared Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
K202767 · LNH
Canon Medical Systems Corporation
Radiology · 116d
Cleared Jan 15, 2021
IMMULITE® 2000 Cortisol
K202826 · CGR
Siemens Healthcare Diagnostics...
Toxicology · 113d
Cleared Jan 15, 2021
AccuBrain
K202847 · LLZ
Brainnow Medical Technology Limited
Radiology · 112d
Cleared Jan 15, 2021
Veuron-Brain-pAb
K203142 · LLZ
Heuron Co., Ltd.
Radiology · 87d
Cleared Jan 15, 2021
AirPhysio Positive Expiratory Pressure (PEP) Device
K203209 · BYI
Airphysio Pty, Ltd.
Anesthesiology · 77d
Cleared Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · CGR
Siemens Healthcare Diagnostics...
Chemistry · 71d
Cleared Jan 15, 2021
Ali Interbody Fusion System
K203308 · MAX
Raed M. Ali, M.D., Inc.
Orthopedic · 66d
Cleared Jan 15, 2021
Dynanail Mini Hybrid
K203381 · HWC
MedShape, Inc.
Orthopedic · 59d