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
25249–25272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2018
HORIZON TMS Therapy System
K180907 · OBP
Magstim Company, Ltd.
Neurology · 119d
Cleared Aug 03, 2018
ASK System
K181146 · JWH
L and K Biomed Corporation Limited
Orthopedic · 94d
Cleared Aug 03, 2018
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
K181149 · IRP
Zenith Technical Innovations
Physical Medicine · 94d
Cleared Aug 03, 2018
PHMB Foam Wound Dressing
K181197 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 88d
Cleared Aug 03, 2018
OptiPillows EPAP Mask
K181219 · LWF
Cpapnea Medical Supply
Ear, Nose, Throat · 88d
Cleared CT Aug 03, 2018
Glidesheath Slender Tibial Pedal Kit
K181237 · DYB
Terumo Medical Corporation
Cardiovascular · 85d
Cleared Aug 03, 2018
Atlas Gold PTA Dilatation Catheter
K181323 · LIT
C.R. Bard, Inc.
Cardiovascular · 77d
Cleared Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
K181479 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Aug 03, 2018
Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior...
K181549 · KWQ
Curiteva, LLC
Orthopedic · 52d
Cleared Aug 03, 2018
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook...
K181796 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Aug 03, 2018
Philips CT Big Bore Sliding Gantry Configuration
K181797 · JAK
Phillips Medical Systems (Cleveland),...
Radiology · 29d
Cleared Aug 03, 2018
GRYPHON® Anchors with DYNACORD™ Suture
K181809 · MAI
Medos International SARL
Orthopedic · 28d
Cleared Aug 02, 2018
Qualisys Clinical System
K171547 · LXJ
Qualisys AB
Physical Medicine · 433d
Cleared Aug 02, 2018
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
K171977 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 398d
Cleared Aug 02, 2018
Neonatal ConchaSmart Breathing Circuits
K173280 · BZE
Teleflexmedical, Inc.
Anesthesiology · 290d
Cleared Aug 02, 2018
Lockbox for Perfusor Space PCA Infusion Pump
K173531 · MRZ
B.Braun Medical, Inc.
General Hospital · 260d
Cleared Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
K173869 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 225d
Cleared Aug 02, 2018
Temporary Cardiac Pacing Wire
K173923 · LDF
Ethicon, Inc.
Cardiovascular · 219d
Cleared Aug 02, 2018
PL8 Wrist Reconstruction Plate
K180150 · HRS
Citieffe S.R.L.
Orthopedic · 195d
Cleared Aug 02, 2018
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K181007 · NEU
Cianna Medical, Inc.
General & Plastic Surgery · 107d
Cleared Aug 02, 2018
Polydioxanone Surgical Scaffold
K181094 · FTL
Lntegra Lifesciences
General & Plastic Surgery · 99d
Cleared Aug 02, 2018
DYNACORD Suture
K181182 · GAT
Medos International SARL
General & Plastic Surgery · 91d
Cleared Aug 02, 2018
PlasmaBlade X 3.0S, PlasmaBlade X 4.0
K181257 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 83d
Cleared Aug 02, 2018
ProVectra 3D Prime with VistaSoft
K181432 · OAS
Durr Dental SE
Radiology · 62d