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
21673–21696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2019
BC-5
K191693 · GEX
Reveallux, Corp
General & Plastic Surgery · 129d
Cleared Nov 01, 2019
Combo Electrotherapy Device
K192087 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 88d
Cleared Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · CFF
Sebia
Immunology · 88d
Cleared Nov 01, 2019
Small VBR™
K192117 · MQP
Ulrich GmbH & Co. KG
Orthopedic · 87d
Cleared Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable...
K192278 · HIH
Uvision360, Inc.
Obstetrics & Gynecology · 71d
Cleared Nov 01, 2019
FDR SE Lite
K192440 · MQB
Fujifilm Corporation
Radiology · 56d
Cleared Oct 31, 2019
mediCAD Web
K183412 · LLZ
Medicad Hectec GmbH
Radiology · 325d
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047 · GZF
Bioness, Inc.
Neurology · 295d
Cleared Oct 31, 2019
Ultrasonic Surgical System
K190281 · LFL
Medisonic Technology CO
General & Plastic Surgery · 262d
Cleared Oct 31, 2019
Claritag
K190747 · GEH
Dgi Technologies
General & Plastic Surgery · 223d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 31, 2019
ePM Series Patient monitors
K191769 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 122d
Cleared Oct 31, 2019
Belimed Steam Sterilizer MST-H TOP 5000
K191896 · FLE
Belimed AG
General Hospital · 108d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 31, 2019
087 Balloon Guide Catheter System
K192525 · DQY
Q'Apel Medical, LLC
Neurology · 48d
Cleared Oct 31, 2019
VisionX 2.4
K192743 · LLZ
Durr Dental SE
Radiology · 31d
Cleared Oct 31, 2019
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
K192867 · GEI
Bovie Medical Corporation Dba Apyx...
General & Plastic Surgery · 24d
Cleared Oct 31, 2019
ADH19
K192961 · KLE
3M Deutschland GmbH
Dental · 9d
Cleared Oct 30, 2019
EZE SIT Valvulotome
K190267 · MGZ
Lemaitre Vascular
Cardiovascular · 264d
Cleared Oct 30, 2019
Arthrex Low Profile Screws
K190921 · HWC
Arthrex, Inc.
Orthopedic · 204d
Cleared Oct 30, 2019
IB3D ALIF
K191134 · MAX
Medicrea International SA
Orthopedic · 184d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · OQY
Ujenzi Charitable Trust
Obstetrics & Gynecology · 173d