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
88393–88416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774 · DQO
Cook, Inc.
Cardiovascular · 298d
Cleared Oct 16, 1998
PENETREASE
K980078 · FMF
P.T. Panca Pusaka Deli
General Hospital · 281d
Cleared Oct 16, 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · JZG
Boehringer Mannheim Corp.
Immunology · 234d
Cleared Oct 16, 1998
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
K980907 · LPS
Axis Biochemicals, Asa
Chemistry · 220d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660 · DSP
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Oct 16, 1998
SERAQUEST RUBELLA IGM
K982281 · LFX
Quest Intl., Inc.
Microbiology · 108d
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 16, 1998
COSMO PLUS WITH NICO, MODEL 8200
K982499 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 88d
Cleared Oct 16, 1998
FLEXIMA
K982508 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Oct 16, 1998
SULLIVAN MIRAGE FULL FACE MASK
K982530 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · HRS
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 16, 1998
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150
K982621 · MVO
Phamatech
Toxicology · 80d
Cleared Oct 16, 1998
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · JOY
Accumed Intl., Inc.
Hematology · 67d
Cleared Oct 16, 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES...
K982866 · JZO
Nichols Institute Diagnostics
Immunology · 63d
Cleared Oct 16, 1998
B-SYSTEM SILICONE
K982917 · ELW
Sybron Dental Specialties, Inc.
Dental · 58d
Cleared Oct 16, 1998
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
K982999 · JKA
Greiner Meditech, Inc.
Chemistry · 50d
Cleared Oct 16, 1998
MYSTIQUE ULTRASONIC NEBULIZER
K983002 · CAF
Airsep Corp.
Anesthesiology · 49d
Cleared Oct 16, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
K983409 · FOZ
Hdc Corp.
General Hospital · 18d
Cleared Oct 15, 1998
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K981360 · LYZ
Glormed Intl., Inc.
General Hospital · 184d
Cleared Oct 15, 1998
BIOCLEAR CONCENTRATE
K981565 · EIA
Waggoner Product Development
Dental · 167d
Cleared Oct 15, 1998
SMOKE-EVAC
K981888 · GEI
Bio-Medical Devices, Inc.
General & Plastic Surgery · 139d
Cleared Oct 15, 1998
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · GJA
Sigma Diagnostics, Inc.
Hematology · 114d
Cleared Oct 15, 1998
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · DTD
Medtronic Vascular
Cardiovascular · 113d
Cleared Oct 15, 1998
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
K982492 · DZE
Imcor
Dental · 90d