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
30217–30240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2017
YOGA Microcatheter
K162563 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Jan 05, 2017
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
K162705 · GGN
Maine Standards Company, LLC
Hematology · 99d
Cleared Jan 05, 2017
Vevazz LED Heat Lamp
K162763 · ILY
Vevazz, LLC
Physical Medicine · 97d
Cleared Jan 05, 2017
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961 · LSE
DiaSorin, Inc.
Microbiology · 73d
Cleared Jan 05, 2017
Sapphire II PRO
K163114 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 59d
Cleared Jan 05, 2017
Arterys Cardio DL
K163253 · LLZ
Arterys, Inc.
Radiology · 48d
Cleared Jan 05, 2017
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters,...
K163454 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 27d
Cleared Jan 04, 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · DQA
Shenzhen Caremed Medical Technology...
Anesthesiology · 428d
Cleared Jan 04, 2017
CephSimulation
K161270 · LLZ
Anatomage, Inc.
Radiology · 244d
Cleared Jan 04, 2017
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
K162223 · LPL
Supervision Optimax Sdn Bhd
Ophthalmic · 149d
Cleared Jan 04, 2017
Truscope Ultra Patient Monitor
K162234 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 148d
Cleared Jan 04, 2017
Relign System
K162770 · GEI
Relign Corporation
General & Plastic Surgery · 93d
Cleared Jan 04, 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959 · LSE
DiaSorin, Inc.
Microbiology · 72d
Cleared Jan 04, 2017
ACUSON P500 Ultrasound System
K163396 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jan 04, 2017
DigitalDiagnost C50
K163410 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 30d
Cleared Jan 04, 2017
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System...
K163424 · FEQ
United State Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 04, 2017
B6
K163429 · OXO
Beijing East Whale Imaging Technology...
Radiology · 28d
Cleared Jan 03, 2017
MOTO Partial Knee System
K162084 · HSX
Medacta International S.A.
Orthopedic · 160d
Cleared Jan 03, 2017
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
K162423 · CAC
Haemonetics Corporation
Anesthesiology · 126d
Cleared Jan 03, 2017
Axium Prime Detachable Coil System
K162704 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 97d
Cleared Jan 03, 2017
Isolator Multifunctional Linear Pen
K163408 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Jan 03, 2017
syngo.via MI Workflows
K163421 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Jan 03, 2017
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
K163427 · IYN
Sonoscape Medical Corp.
Radiology · 28d
Cleared Dec 30, 2016
NuFACE Gel Primer
K161654 · GYB
Carol Cole Company
Neurology · 198d