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
73513–73536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 13, 2002
COOPERSURGICAL TRIAL TRANSFER CATHETER
K023384 · MQF
Cooper Surgical
Obstetrics & Gynecology · 66d
Cleared Dec 13, 2002
SPERMGRAD, MODELS 10022/10063
K023403 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466 · ELW
Cavex Holland BV
Dental · 58d
Cleared Dec 13, 2002
BIOLOY
K023477 · EJH
Neirynck & Vogt NV
Dental · 58d
Cleared Dec 13, 2002
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K023491 · FRN
Help Technologies
General Hospital · 57d
Cleared Dec 13, 2002
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
K023500 · FLL
Innovatech, Inc.
General Hospital · 56d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d