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

Filters: Cleared only ×
175,820 results
122977–123000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 04, 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · CBK
Mallinckrodt Medical
Anesthesiology · 277d
Cleared Mar 04, 1991
AIR PLUS NEBULIZER
K902520 · BTI
Diamond Medical Equipment, Inc.
Anesthesiology · 270d
Cleared Mar 04, 1991
VARIOUS MALE QUICK CONNECTS.
K905091 · BYX
Medical Fittings, Inc.
Anesthesiology · 110d
Cleared Mar 04, 1991
DELUXE SANITARY PAD
K905178 · HHD
American Healthcare Corp.
Obstetrics & Gynecology · 105d
Cleared Mar 04, 1991
NEON RUBBER SUNGLASSES
K905183 · HQZ
Ha-Lo Advertising Specialties, Inc.
Ophthalmic · 105d
Cleared Mar 04, 1991
LAPAROSCOPE
K905196 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 104d
Cleared Mar 04, 1991
KTP DISC KIT
K905424 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 04, 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · DZE
Nobelpharma USA, Inc.
Dental · 90d
Cleared Mar 04, 1991
SURGICAL FACE MASK
K905749 · FXX
Anago, Inc.
General Hospital · 70d
Cleared Mar 04, 1991
APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
K905781 · MEH
Intermedics Orthopedics
Orthopedic · 66d