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
40201–40224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2013
HERMES MEDICAL IMAGING SUITE V5.3
K131233 · KPS
Hermes Medical Solutions AB
Radiology · 76d
Cleared Jul 16, 2013
BD PEN NEEDLE
K131358 · FMI
Becton, Dickinson & CO
General Hospital · 67d
Cleared Jul 16, 2013
RADVISION
K131428 · MUJ
Acoustic Medsystems, Inc.
Radiology · 60d
Cleared Jul 16, 2013
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K131434 · GWG
Visionsense, Ltd.
Neurology · 60d
Cleared Jul 16, 2013
UNIVERSAL OPAQUE
K131504 · EBF
Shofu Dental Corporation
Dental · 53d
Cleared Jul 15, 2013
25OH VITAMIN D TOTAL ELISA TEST
K123364 · MRG
Diasource Immunoassays, S.A.
Chemistry · 256d
Cleared Jul 15, 2013
611 ANKLE FUSION NAIL
K130051 · HSB
Tornier S.A.S.
Orthopedic · 187d
Cleared Jul 15, 2013
DENTEK EASY BRUSH WITH FLUORIDE
K130186 · EFW
Den Tek Oral Care, Inc.
Dental · 171d
Cleared Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
K130253 · PER
Beckman Coulter, Inc.
Immunology · 164d
Cleared Jul 15, 2013
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
K130360 · DRG
Constant Care, LLC
Cardiovascular · 152d
Cleared Jul 15, 2013
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL...
K130585 · MUH
VATECH Co., Ltd.
Radiology · 132d
Cleared Jul 15, 2013
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
K130657 · NBW
All Medicus Co., Ltd.
Chemistry · 125d
Cleared Jul 15, 2013
NEOTIS
K130953 · MQV
Sbm Sciences For Bio Materials
Orthopedic · 101d
Cleared Jul 15, 2013
EXTAVIPRO STERICAN 30G
K131040 · FMI
B.Braun Melsungen AG
General Hospital · 91d
Cleared Jul 15, 2013
ANA SCREEN ELISA (IGG)
K131185 · LJM
Euroimmun US
Immunology · 80d
Cleared Jul 15, 2013
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION...
K131382 · MWI
Invivo Corporation
Cardiovascular · 62d
Cleared Jul 15, 2013
TRUSCOPE SERIES PATIENT MONITOR
K131763 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 28d
Cleared Jul 12, 2013
SURGITRON 4.0 DUAL RF S5-IEC
K123366 · GEI
Ellman International, Inc.
General & Plastic Surgery · 254d
Cleared Jul 12, 2013
INGENUITY DIGITAL PET/CT
K123599 · KPS
Philips Healthcare (Cleveland)
Radiology · 233d
Cleared Jul 12, 2013
IPULSE HAIR REMOVAL SYSTEM
K130315 · OHT
Cyden Limited
General & Plastic Surgery · 154d
Cleared Jul 12, 2013
SOLEA
K130420 · GEX
Convergent Dental, Inc.
General & Plastic Surgery · 143d
Cleared Jul 12, 2013
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K130806 · PDQ
Neurovision Medical Products, Inc.
Neurology · 109d
Cleared Jul 12, 2013
YAMAHACHI DENTURE BASE RESINS
K131036 · EBI
Yamahachi Dental Manufacturing Co.
Dental · 88d
Cleared Jul 12, 2013
SHARPSTANK REUSABLE SHARPS CONTAINER
K131087 · MMK
Rehrig Pacific Company
General Hospital · 85d