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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70441–70464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915 · JAK
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 30, 2003
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891,...
K033016 · GZB
Medtronic Neurological
Neurology · 34d
Cleared Oct 30, 2003
HANDIVIPP
K033125 · IOR
Handinor USA, Inc.
Physical Medicine · 30d
Cleared Oct 30, 2003
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 30, 2003
MECHANICAL WHEEHCHAIR
K033141 · IOR
Pacific Medical Suppliers, Inc.
Physical Medicine · 30d
Cleared Oct 30, 2003
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
K033172 · GEX
Candela Corp.
General & Plastic Surgery · 30d
Cleared Oct 30, 2003
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · JEY
Inion , Ltd.
Dental · 28d
Cleared Oct 30, 2003
ENSITE SYSTEM
K033211 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 27d
Cleared Oct 30, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS
K033212 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 27d
Cleared Oct 30, 2003
ARTHROCARE ENT PLASMA WANDS
K033257 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Oct 29, 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
K023000 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 415d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 289d
Cleared Oct 29, 2003
STICK FLOW
K031341 · EBF
Stick Tech , Ltd.
Dental · 184d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH...
K032024 · LZA
Shen Wei (Usa), Inc.
General Hospital · 121d
Cleared Oct 29, 2003
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared Oct 29, 2003
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
K032119 · KCT
Paragon Medical, Inc.
General Hospital · 112d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 86d
Cleared Oct 29, 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · MQN
KLS-Martin L.P.
Dental · 82d
Cleared Oct 29, 2003
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
K032599 · GEX
Medical Laser Technologies, LLC
General & Plastic Surgery · 65d
Cleared Oct 29, 2003
XTRAK SUPPORT CATHETER
K032660 · DQY
Xtrak Medical, Inc.
Cardiovascular · 62d
Cleared Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · LLZ
Vital Images, Inc.
Radiology · 54d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962 · FOZ
Arrow Intl., Inc.
General Hospital · 36d
Cleared Oct 29, 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · MQN
Synthes (Usa)
Dental · 30d