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
37105–37128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2014
MARATHON NO STING LIQUID SKIN PROTECTANT
K133443 · KMF
Advanced Medical Solutions...
General & Plastic Surgery · 240d
Cleared Jul 10, 2014
VERADIUS
K133819 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 206d
Cleared Jul 10, 2014
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
K140101 · GCJ
Ab Medica Sas
General & Plastic Surgery · 176d
Cleared Jul 10, 2014
MELUNA CLASSIC/SPORT MENSTRUAL CUP
K140626 · HHE
Meluna
Obstetrics & Gynecology · 121d
Cleared Jul 10, 2014
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
K140658 · GEI
Conmed Corporation
General & Plastic Surgery · 118d
Cleared Jul 10, 2014
RANGE/MESA/DENALI SPINAL SYSTEM
K140765 · NKB
K2m, Inc.
Orthopedic · 105d
Cleared Jul 10, 2014
ENADEN FLOW
K140976 · EBF
Km Corporation
Dental · 85d
Cleared Jul 10, 2014
3D EPTFE
K141027 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 79d
Cleared Jul 09, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K134005 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Jul 09, 2014
FLENTS PLASTIC EYE WASH CUP
K140409 · LXQ
Apothecary Products, Inc.
Ophthalmic · 141d
Cleared Jul 09, 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 141d
Cleared Jul 09, 2014
MERIT SAFETY INTRODUCER NEEDLE
K140513 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 131d
Cleared Jul 09, 2014
BIOFOAM BONE WEDGE
K140531 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 127d
Cleared Jul 09, 2014
INTRODUCER, MODEL ADELANTE MAGNUM
K140917 · DYB
Oscor, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2014
ETEX MIXING AND DELIVERY SYSTEM
K141245 · FMF
Etex Corporation
General Hospital · 56d
Cleared Jul 09, 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 41d
Cleared Jul 09, 2014
IMMULITE 2000
K141444 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jul 08, 2014
WIRELESS THERMOMETER
K132761 · FLL
Raiing Medical Company
General Hospital · 307d
Cleared Jul 08, 2014
RESTORIS POROUS PARTIAL KNEE SYSTEM
K133811 · NJD
Mako Surgical Corp.
Orthopedic · 204d
Cleared Jul 08, 2014
BENDA WEDGE
K140144 · EJB
Centrix, Inc.
Dental · 167d
Cleared Jul 08, 2014
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
K140643 · MAI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 118d
Cleared Jul 08, 2014
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K140816 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 98d
Cleared Jul 08, 2014
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · FRN
Hospira, Inc.
General Hospital · 70d
Cleared Jul 08, 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K141117 · FMI
Vidacare, LLC
General Hospital · 69d