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
72985–73008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 13, 2002
A1CNOW FOR HOME USE
K022661 · LCP
Metrika, Inc.
Hematology · 126d
Cleared Dec 13, 2002
INFANT/CHILD REDUCED ENERGY ELECTRODES
K022732 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 119d
Cleared Dec 13, 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K022773 · LLZ
Barco N.V.
Radiology · 114d
Cleared Dec 13, 2002
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
K022905 · MSD
Horizon Medical Products, Inc.
Gastroenterology & Urology · 101d
Cleared Dec 13, 2002
TUCKER EMBRYO CATHETER
K023017 · MQF
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 94d
Cleared Dec 13, 2002
COMPREHENSIVE HUMERAL FRACTURE SYSTEM
K023063 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 13, 2002
UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
K023129 · HIS
Unidus Corp.
Obstetrics & Gynecology · 85d
Cleared Dec 13, 2002
UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
K023175 · HIS
Unidus Corp.
Obstetrics & Gynecology · 81d
Cleared Dec 13, 2002
UNDUS MALE LATEX CONDOM (WITH FLAVORING)
K023176 · HIS
Unidus Corp.
Obstetrics & Gynecology · 81d