FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
17401–17424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
K203557 · LPH
Encore Medical, L.P.
Orthopedic · 65d
Cleared Feb 10, 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X...
K203632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Feb 09, 2021
SmartCT R1.0
K201583 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 243d
Cleared Feb 09, 2021
Concerto Versa, Detachable Coil
K202850 · KRD
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 134d
Cleared Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
K203055 · GWO
Stryker
Neurology · 124d
Cleared Feb 09, 2021
MR Conditional Sticky Pad Electrode
K203079 · GXY
Rhythmlink International, LLC
Neurology · 119d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Fujifilm Corporation
Radiology · 118d
Cleared Feb 09, 2021
nPro Surgical Mask
K203265 · FXX
Np Medical, Inc.
General Hospital · 96d
Cleared Feb 09, 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7,...
K210083 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Feb 09, 2021
LIAISON Anti-HAV
K210272 · LOL
DiaSorin, Inc.
Microbiology · 8d
Cleared Feb 08, 2021
Straumann 4 mm Short Implants
K202942 · DZE
Straumann USA, LLC
Dental · 131d
Cleared Feb 08, 2021
HydroMID
K203069 · FOZ
Access Vascular, Inc.
General Hospital · 122d
Cleared Feb 06, 2021
SPEAC System
K200276 · POS
Brain Sentinel, Inc.
Neurology · 368d
Cleared Feb 06, 2021
MouthLab Vital Signs Monitoring System
K201635 · MWI
Multisensor Diagnostics (Dba Aidar...
Cardiovascular · 235d
Cleared Feb 05, 2021
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal...
K200320 · GDW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 364d
Cleared Feb 05, 2021
LINK Embrace Shoulder System - Reverse Configuration
K200368 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 357d
Cleared Feb 05, 2021
Shofu Block HC Hard
K200470 · EBF
Shofu Dental Corporation
Dental · 345d
Cleared Feb 05, 2021
Sphincterotome
K201121 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 284d
Cleared Feb 05, 2021
HAMILTON-C3
K201306 · CBK
Hamilton Medical AG
Anesthesiology · 266d
Cleared Feb 05, 2021
Antibacterial Bandage
K201324 · FRO
Jiangsu Excellence Medical Supplies...
General & Plastic Surgery · 263d
Cleared Feb 05, 2021
Dukal Corporation Level 2 Surgical Mask with Ear Loops
K201421 · FXX
Dukal Corporation
General Hospital · 252d
Cleared Feb 05, 2021
Bonelogic
K203290 · LLZ
Disior, Ltd.
Radiology · 88d
Cleared Feb 05, 2021
GentleWave X
K203302 · ELC
Sonendo, Inc.
Dental · 88d
Cleared Feb 05, 2021
SYMPHONY™ OCT System
K203319 · NKG
Medos International SARL
Orthopedic · 85d