Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
74113–74136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 13, 2002
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114...
K023212 · GXY
Ag Garments
Neurology · 78d
Cleared Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229 · IZH
American Mammographics, Inc.
Radiology · 77d
Cleared Dec 13, 2002
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · BSO
Ebi, L.P.
Anesthesiology · 77d
Cleared Dec 13, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K023243 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 74d
Cleared Dec 13, 2002
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
K023261 · GCJ
Taut, Inc.
General & Plastic Surgery · 74d
Cleared Dec 13, 2002
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
K023292 · MUH
Krugman Technologies, Inc.
Radiology · 72d
Cleared Dec 13, 2002
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K023383 · MQF
Cooper Surgical
Obstetrics & Gynecology · 66d