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
115681–115704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1992
FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE
K924012 · IXK
Fujifilm Medical System U.S.A., Inc.
Radiology · 67d
Cleared Oct 16, 1992
POLIBOND
K924181 · KLE
Voco GmbH
Dental · 58d
Cleared Oct 16, 1992
CALCIMOL LC
K924182 · EJK
Voco GmbH
Dental · 58d
Cleared Oct 16, 1992
ALPHA-DENT PIT AND FISSURE SEALANT
K924635 · EBC
Wallace A. Erickson & Co.
Dental · 53d
Cleared Oct 16, 1992
BATTERY PACK
K924798 · IZL
Portable Power Systems, Inc.
Radiology · 22d
Cleared Oct 15, 1992
LINEAR ACCELERATOR COLLIMATOR
K911973 · IYE
Medical Equipment Development Co., Inc.
Radiology · 531d
Cleared Oct 15, 1992
COMET C-125
K914748 · OXO
Fischer Imaging Corp.
Radiology · 359d
Cleared Oct 15, 1992
GUARDALL SHIELD
K915415 · LYU
Anago, Inc.
General Hospital · 321d
Cleared Oct 15, 1992
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
K920145 · LZO
Biopro, Inc.
Orthopedic · 276d
Cleared Oct 15, 1992
SOFNOLIME CARBON DIOXIDE ABSORBENT
K921803 · CBL
Molecular Products , Ltd.
Anesthesiology · 183d
Cleared Oct 15, 1992
ARTHREX ARTHROSCOPY ICE BLADE
K921823 · HRX
Arthrex, Inc.
Orthopedic · 182d
Cleared Oct 15, 1992
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
K921875 · IZO
Continental X-Ray Corp.
Radiology · 178d
Cleared Oct 15, 1992
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
K922421 · JDI
Kinamed, Inc.
Orthopedic · 147d
Cleared Oct 15, 1992
X-RAY DRAPES
K923099 · IWQ
Hydro-Med Products, Inc.
Radiology · 112d
Cleared Oct 15, 1992
BOSTON BRAND HYPOALLERGENIC LATEX GLOVES
K923385 · LYY
Boston Medical Corp.
General Hospital · 100d
Cleared Oct 15, 1992
CK-NAC ACTIVATED KIT
K923511 · CGS
Randox Laboratories, Ltd.
Chemistry · 92d
Cleared Oct 15, 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571 · CDP
Syva Co.
Chemistry · 90d
Cleared Oct 15, 1992
HEART NEBULIZER
K923596 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 87d
Cleared Oct 15, 1992
CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER
K923683 · GEX
Cynosure, Inc.
General & Plastic Surgery · 84d
Cleared Oct 15, 1992
NITINOL GENTLE TOUCH COIL SPRING
K923839 · DZC
Ultimate Wireforms, Inc.
Dental · 77d
Cleared Oct 15, 1992
SD-605 SD II PROGRAM
K923935 · GZJ
Skylark Device Co., Ltd.
Neurology · 71d
Cleared Oct 15, 1992
OPUS(R) CK-MB
K924429 · JHY
Pb Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Oct 15, 1992
MICRO-PLATE OPIATES ASSAY
K924446 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 44d
Cleared Oct 15, 1992
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
K924599 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 34d