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
25825–25848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2018
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K180402 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 100d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · FCX
Fujifilm Corporation
Gastroenterology & Urology · 67d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · NDY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared May 25, 2018
ProtekDuo Mini Veno-Venous Cannula Set
K181150 · DWF
Cardiacassist, Inc.
Cardiovascular · 24d
Cleared May 24, 2018
GBR system
K170697 · JEY
Surgident
Dental · 443d
Cleared May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS...
K172582 · MOB
Euroimmun Us, Inc.
Immunology · 269d
Cleared May 24, 2018
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome,...
K172665 · KNS
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 261d
Cleared May 24, 2018
T2Bacteria Panel
K172708 · QBX
T2biosystems, Inc.
Microbiology · 258d
Cleared May 24, 2018
IS-III HActive Fixture
K173938 · DZE
Neobiotech Co., Ltd.
Dental · 149d
Cleared May 24, 2018
EPX-4440FN Digital Video Processor with Light Source
K180414 · FET
Fujifilm New Development U.S.A., Inc.
Gastroenterology & Urology · 98d
Cleared May 24, 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · KPR
Samsung Electronics Co., Ltd.
Radiology · 84d
Cleared May 24, 2018
Safety Wire Guide Introducer
K180756 · EZN
Cook Incorporated
Gastroenterology & Urology · 63d
Cleared May 24, 2018
Celling Aspiration Needle
K180807 · KNW
Spine Smith Holdings, LLC
Gastroenterology & Urology · 57d
Cleared May 24, 2018
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound...
K180862 · IYN
Edan Instruments, Inc.
Radiology · 52d
Cleared May 24, 2018
PIXX 1717
K180976 · MQB
Pixxgen Corporation
Radiology · 41d
Cleared May 24, 2018
ActiGraph CentrePoint Insight Watch
K181077 · LEL
Actigraph
Neurology · 30d
Cleared May 24, 2018
McKesson Cardiology
K181080 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 30d
Cleared May 24, 2018
Fresenius Liberty Select Cycler
K181108 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 27d
Cleared May 24, 2018
CS 9600
K181136 · OAS
Trophy
Radiology · 24d
Cleared May 23, 2018
PATRIOT COLONIAL Spacer, SUSTAIN Spacer
K173722 · ODP
Globus Medical, Inc.
Orthopedic · 169d
Cleared May 23, 2018
Route 92 Medical Access System
K180201 · DQY
Route 92 Medical, Inc.
Cardiovascular · 119d
Cleared May 23, 2018
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length
K180403 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 98d
Cleared May 23, 2018
Rodo Smilekey
K180609 · NHA
Rodo Medical, Inc.
Dental · 76d
Cleared May 23, 2018
Biograph Vision
K180811 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 55d