FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118777–118800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1991
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913082 · FLL
Respiratory Support Products, Inc.
General Hospital · 202d
Cleared Dec 11, 1991
DEVILBISS MODEL 7427D
K913316 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 140d
Cleared Dec 10, 1991
CHALLENGE 3000 NEUROLOGICAL BOOSTER
K903148 · IPF
Maximum Performance Technologies,...
Physical Medicine · 510d
Cleared Dec 10, 1991
CR SPIRAL ELECTRODE
K910815 · HGP
Neward Enterprises, Inc.
Obstetrics & Gynecology · 287d
Cleared Dec 10, 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · GZJ
Medtronic Vascular
Neurology · 222d
Cleared Dec 10, 1991
HEXLOCK
K912262 · DZE
Imtec Corp.
Dental · 202d
Cleared Dec 10, 1991
RETRIEVAL DEVICE
K914067 · DQO
Target Therapeutics
Cardiovascular · 90d
Cleared Dec 10, 1991
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 83d
Cleared Dec 10, 1991
ALBUMIN TEST RID KIT
K914391 · DCF
The Binding Site, Ltd.
Immunology · 70d
Cleared Dec 10, 1991
MICRO EIA FOR COCAINE METABOLITES
K914533 · DIO
Microdiagnostics, Inc.
Toxicology · 60d
Cleared Dec 10, 1991
CHROMATOGRAPHY CLINICAL USE 75JQR
K914841 · KIE
Millipore Corp.
Toxicology · 46d
Cleared Dec 09, 1991
VIDENT IMPAC IMPLANT ACCESSORIES
K904391 · DZE
Vident
Dental · 440d
Cleared Dec 09, 1991
IV 1000 INSUFFLATOR RAPID FLOW
K910983 · HIF
M.D. Engineering, Inc.
Obstetrics & Gynecology · 277d
Cleared Dec 09, 1991
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · MID
Immuno Concepts, Inc.
Immunology · 241d
Cleared Dec 09, 1991
LATEX EXAMINATION GLOVES
K912040 · LYY
Pt. Indoraya Everlatex
General Hospital · 215d
Cleared Dec 09, 1991
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · HRX
3M Company
Orthopedic · 210d
Cleared Dec 09, 1991
DR. LIBERSON'S MICROPULSE NEUROMUSCULAR TRANS STIM
K912342 · IPF
Amer Inst of...
Physical Medicine · 199d
Cleared Dec 09, 1991
EMS300, EMS400, EMS8000
K912642 · IPF
Skylark Device Co., Ltd.
Physical Medicine · 178d
Cleared Dec 09, 1991
ORTHODONTIC HEADGEAR
K912682 · DZB
K-Tek Orthodontic Products
Dental · 179d
Cleared Dec 09, 1991
DANTEC MENUET
K912701 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 173d
Cleared Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 171d
Cleared Dec 09, 1991
RSV-MAB TEST
K912842 · LKT
Gull Laboratories, Inc.
Microbiology · 166d
Cleared Dec 09, 1991
SOMATOSENSORY STIMULUS SYSTEM
K913604 · GZP
Biomagnetic Technologies, Inc.
Neurology · 117d
Cleared Dec 09, 1991
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
K913666 · DEM
The Binding Site, Ltd.
Immunology · 112d