FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122953–122976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1991
MONTROSE DRESSING APPLICATORS
K905519 · NAD
Olemunda Pty , Ltd.
General & Plastic Surgery · 89d
Cleared Mar 06, 1991
CRP LIPID REAGENT TEST PACK
K905648 · CHH
Cirrus Diagnostics, Inc.
Chemistry · 79d
Cleared Mar 06, 1991
MICRO-X 80HF
K905695 · IZO
Fischer Imaging Corp.
Radiology · 77d
Cleared Mar 06, 1991
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
K905759 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 69d
Cleared Mar 06, 1991
DRAINAGE TUBE RESTRAINT/WOUND COVER
K905766 · GBX
M. Imonti and Associates Inc.,
General & Plastic Surgery · 69d
Cleared Mar 06, 1991
ORTHOVISION TABLE
K905816 · JEB
American Sterilizer Co.
General & Plastic Surgery · 68d
Cleared Mar 06, 1991
ANTI-FOR SURGICAL FACE MASK
K905865 · FXX
Anago, Inc.
General Hospital · 72d
Cleared Mar 06, 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · JZG
Diagnostic Products Corp.
Immunology · 58d
Cleared Mar 06, 1991
HEMAGEN ENA SCREENING KIT
K910232 · LLL
Hemagen Diagnostics, Inc.
Immunology · 47d
Cleared Mar 06, 1991
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51
K910276 · ITY
Inmark Corp.
Radiology · 42d
Cleared Mar 06, 1991
KEY COMFORT GRIPS
K910328 · FSM
Key Surgical, Inc.
General & Plastic Surgery · 40d
Cleared Mar 06, 1991
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · JGS
Baxter Healthcare Corp
Chemistry · 34d
Cleared Mar 06, 1991
DI2000/HS-45-150 X-RAY TUBE INSERT
K910842 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 7d
Cleared Mar 05, 1991
FUJINON EVL-F (TENTATIVE) AND TROCAR
K902197 · HET
Fujinon, Inc.
Obstetrics & Gynecology · 293d
Cleared Mar 05, 1991
ALTA(R) PFX IM ROD
K903526 · HSB
Howmedica Corp.
Orthopedic · 211d
Cleared Mar 05, 1991
QUICK-CLIP NEEDLE GUIDE
K903561 · ITX
Acuson Corp.
Radiology · 210d
Cleared Mar 05, 1991
OPTILASE (TM) MODEL 900 ARGON
K903838 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 196d
Cleared Mar 05, 1991
ESI-3000 ULTRASOUND SYSTEM
K904359 · IYN
Elscint, Inc.
Radiology · 162d
Cleared Mar 05, 1991
SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
K904396 · BZQ
Simplex Medical Systems, Inc.
Anesthesiology · 161d
Cleared Mar 05, 1991
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
K904793 · FGB
Surgitek
Gastroenterology & Urology · 133d
Cleared Mar 05, 1991
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)
K904797 · FBO
Surgitek
Gastroenterology & Urology · 133d
Cleared Mar 05, 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
K905264 · JGS
Nova Biomedical Corp.
Chemistry · 104d
Cleared Mar 05, 1991
MANGAR BOOSTER
K905414 · FNG
Northfleet Management Group, Inc.
General Hospital · 92d