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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122377–122400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 05, 1991
SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
K905451 · JDX
Advanced Osseous Technologies
Orthopedic · 90d
Cleared Mar 05, 1991
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
K905453 · HQF
Douglas James Donaldson Compliance...
Ophthalmic · 90d
Cleared Mar 05, 1991
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
K905461 · EKS
Angiosystems, Inc.
Dental · 90d
Cleared Mar 05, 1991
CODMAN NEUROLASE LASER SYSTEM/MODIFICATION
K905511 · GEX
I.L. Med, Inc.
General & Plastic Surgery · 88d
Cleared Mar 05, 1991
SOLID CORE GUTTA PERCHA CARRIER
K905640 · EKS
The Hygenic Corp.
Dental · 78d
Cleared Mar 05, 1991
THE UNIVERSAL CEMENT PLUG(TM)
K910135 · LZN
Biotron , Ltd.
Orthopedic · 55d
Cleared Mar 05, 1991
EF SYNERGY QUAD MODIFIED
K910242 · JWY
Remel Co.
Microbiology · 42d
Cleared Mar 05, 1991
ARTIFLEX(TM)
K910274 · LGF
Beiersdorf, Inc.
Orthopedic · 41d
Cleared Mar 05, 1991
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
K910517 · DHB
Pharmacia, Inc.
Immunology · 28d
Cleared Mar 05, 1991
FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR
K910746 · IOR
Fortress Litestyle
Physical Medicine · 12d
Cleared Mar 05, 1991
FORTRESS EDGE MANUAL RIGID WHEELCHAIR
K910748 · IOR
Fortress Litestyle
Physical Medicine · 12d
Cleared Mar 05, 1991
FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR
K910750 · IOR
Fortress Litestyle
Physical Medicine · 12d
Cleared Mar 05, 1991
FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR
K910752 · IOR
Fortress Litestyle
Physical Medicine · 12d
Cleared Mar 04, 1991
COMPACT LASER IMAGER, MODEL CLI-100
K902347 · LMC
Lumisys, Inc.
Radiology · 283d