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
72217–72240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · LCX
Unipath , Ltd.
Chemistry · 60d
Cleared May 02, 2003
ANA DETECT
K030929 · LJM
Orgentec Diagnostika GmbH
Immunology · 39d
Cleared May 02, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030997 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 35d
Cleared May 02, 2003
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES...
K031062 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 29d
Cleared May 02, 2003
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · DTZ
Dideco S.P.A.
Cardiovascular · 14d
Cleared May 02, 2003
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · FRC
Advanced Sterilization Products
General Hospital · 14d
Cleared May 02, 2003
GE PROPELLER IMAGING OPTION FOR MRI
K031230 · LNH
GE Medical Systems
Radiology · 14d
Cleared May 02, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
K031257 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 11d
Cleared May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · MSW
Beckman Coulter, Inc.
Immunology · 11d
Cleared May 02, 2003
ACCESS OV MONITOR ASSAY
K031297 · LTK
Beckman Coulter, Inc.
Immunology · 8d
Cleared May 01, 2003
SMALL VOLUME NEBULIZER
K023602 · CAF
Allegiance Healthcare Corporation
Anesthesiology · 185d
Cleared May 01, 2003
SUNPEX TECHNOLOGIES MODEL PW
K024175 · ITI
Sunpex Technology Co., Ltd.
Physical Medicine · 134d
Cleared May 01, 2003
CHUMP
K030017 · IOR
Colours 'N Motion
Physical Medicine · 119d
Cleared May 01, 2003
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
K030432 · ITI
Imc-Heart Way LLC
Physical Medicine · 80d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 80d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · LPH
Zimmer, Inc.
Orthopedic · 52d
Cleared May 01, 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
K030741 · MID
Hycor Biomedical , Ltd.
Immunology · 52d
Cleared May 01, 2003
LITTLE COACH
K030759 · INI
Wheelchair & Scooter Express
Physical Medicine · 51d
Cleared May 01, 2003
PASCO MIC AND MIC/ID PANELS
K030933 · JWY
Pasco Laboratories, Inc.
Microbiology · 37d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared May 01, 2003
MEDIPALM-20
K031202 · OLV
Braebon Medical Corp.
Neurology · 15d
Cleared Apr 30, 2003
HEMO-STREAM HEMODIALYSIS CATHETER SET
K023847 · MSD
Rex Medical
Gastroenterology & Urology · 162d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · DJR
American Bio Medica Corp.
Toxicology · 161d
Cleared Apr 30, 2003
ATHENA PELVIC MUSCLE TRAINER
K023905 · KPI
Athena Feminine Technologies, Inc.
Gastroenterology & Urology · 159d