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
73489–73512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2002
STERI-SPOUTS
K023539 · LHI
Valumed
General Hospital · 56d
Cleared Dec 17, 2002
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
K023560 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 55d
Cleared Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
K023867 · JJY
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · GEI
Arthrex, Inc.
General & Plastic Surgery · 15d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482 · HNO
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
K021699 · LYL
Autolens, Inc.
Ophthalmic · 208d
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · JHI
Sa Scientific, Inc.
Chemistry · 126d
Cleared Dec 16, 2002
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000,...
K022762 · DQX
Jomed, Inc.
Cardiovascular · 118d
Cleared Dec 16, 2002
PREG-Q EARLY PREGNANCY TEST
K023027 · LCX
Yd Diagnostics
Chemistry · 96d
Cleared Dec 16, 2002
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
K023081 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 16, 2002
GELSPHERES EMBOLIC AGENT
K023089 · HCG
Biocure, Inc.
Neurology · 90d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
K023101 · LAF
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN AMPHETAMINE TEST
K023104 · DKZ
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
K023109 · LCM
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316 · DLJ
Lin-Zhi International, Inc.
Toxicology · 74d
Cleared Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN...
K023361 · LON
Dade Behring, Inc.
Microbiology · 70d
Cleared Dec 16, 2002
ABBOTT ARCHITECT FOLATE
K023397 · CGN
Abbott Laboratories
Chemistry · 68d
Cleared Dec 16, 2002
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · HIS
Armkel, LLC
Obstetrics & Gynecology · 67d
Cleared Dec 16, 2002
QUICKTOX MULTIPLE DRUG DIPCARD
K023489 · DIO
Branan Medical Corp.
Toxicology · 60d
Cleared Dec 13, 2002
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K020899 · BTL
Pneupac , Ltd.
Anesthesiology · 268d
Cleared Dec 13, 2002
HA ORBITAL IMPLANT
K021643 · HPZ
Laboratoire Villanova
Ophthalmic · 207d