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
22153–22176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2019
Holinwon 30
K183563 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 259d
Cleared Sep 05, 2019
GM501 Wash
K190383 · MQL
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 198d
Cleared Sep 05, 2019
bili-hut
K190899 · LBI
Little Sparrows Technologies, Inc.
General Hospital · 150d
Cleared Sep 05, 2019
SmarTemp X1
K190930 · EBG
Parkell, Inc.
Dental · 148d
Cleared Sep 05, 2019
Advocate Non-Contact Infrared Thermometer
K191004 · FLL
Broadmaster Biotech, Corp.
General Hospital · 142d
Cleared Sep 05, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
K191343 · MED
STERIS Corporation
General Hospital · 108d
Cleared Sep 05, 2019
Persona Revision Knee System
K191625 · JWH
Zimmer, Inc.
Orthopedic · 79d
Cleared Sep 05, 2019
FlowTriever Retrieval/Aspiration System
K191710 · QEW
Inari Medical
Cardiovascular · 71d
Cleared Sep 05, 2019
Dual-Safety Pen Needle
K191853 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 57d
Cleared Sep 05, 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator...
K192020 · JOJ
STERIS Corporation
General Hospital · 38d
Cleared Sep 05, 2019
3M Clarity Aligners
K192119 · NXC
3M Company
Dental · 30d
Cleared Sep 05, 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip,...
K192123 · LCX
Qingdao Hightop Biotech Co., Ltd.
Chemistry · 30d
Cleared Sep 05, 2019
Freedom Primary PCK
K192148 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 28d
Cleared Sep 04, 2019
K3
K183347 · EIA
Osstem Implant Co., Ltd.
Dental · 275d
Cleared Sep 04, 2019
Opus Bulk Fill APS, Opus Bulk Fill Flow APS
K190758 · EBF
Dentscare Ltda
Dental · 163d
Cleared Sep 04, 2019
Akesis Galaxy
K190844 · IWB
Akesis, Inc.
Radiology · 156d
Cleared Sep 04, 2019
VPS Impression Material
K191034 · ELW
Hygedent, Inc.
Dental · 139d
Cleared Sep 04, 2019
Signia Small Diameter Reloads
K191070 · GDW
Covidien
General & Plastic Surgery · 135d
Cleared Sep 04, 2019
Myo Plus
K191179 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 125d
Cleared Sep 04, 2019
MobileRay Pulse SE Digital Imaging System
K191503 · OWB
Portavision Medical, LLC
Radiology · 90d
Cleared Sep 04, 2019
MTS Imipenem 0.016-256 µg/mL
K191908 · JWY
Liofilchem S. R. L.
Microbiology · 50d
Cleared Sep 04, 2019
GOLNIT Non-aborbable PTFE Surgical Suture
K192088 · NBY
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 30d
Cleared Sep 04, 2019
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · CFN
The Binding Site Group , Ltd.
Immunology · 29d
Cleared Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · HRX
Smith & Nephew, Inc.
General & Plastic Surgery · 26d