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
70129–70152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2003
POWERED WHEELCHAIR, MODEL FR168W
K033370 · ITI
Freerider Corp
Physical Medicine · 38d
Cleared Nov 28, 2003
CWAS 1000
K033452 · IKN
Fasstech
Neurology · 29d
Cleared Nov 28, 2003
MALIS IRRIGATION MODULE 1000
K033499 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 28, 2003
ARTHROCARE ARTHROWANDS
K033584 · GEI
Arthrocare Corp.
General & Plastic Surgery · 15d
Cleared Nov 26, 2003
OPTIMESH
K014200 · EZX
Spineology, Inc.
General & Plastic Surgery · 705d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · KWD
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · LLZ
Eastman Kodak Company
Radiology · 231d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524 · JAQ
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Nov 26, 2003
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
K032230 · DQD
Thinklabs, Inc.
Cardiovascular · 128d
Cleared Nov 26, 2003
CEMSTOP CEMENT RESTRICTOR
K032685 · LZN
Teknimed, S.A.
Orthopedic · 89d
Cleared Nov 26, 2003
RENOVA INTERNAL HEX IMPLANT SYSTEM
K032774 · DZE
Lifecore Biomedical, Inc.
Dental · 79d
Cleared Nov 26, 2003
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · MJH
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
HERPES GROUP IGG
K033059 · LGC
Trinity Biotech, Inc.
Microbiology · 58d
Cleared Nov 26, 2003
MYCOPLASMA IGG
K033064 · LON
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
PYLORI IGG
K033067 · LYR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K033070 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079 · LJC
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K033083 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · MSX
Datex-Ohmeda
Cardiovascular · 43d
Cleared Nov 26, 2003
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
K033292 · MOS
Igc-Medical Advances, Inc.
Radiology · 43d
Cleared Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 43d
Cleared Nov 26, 2003
FOSSA URETERAL OPEN LUMEN STENT
K033368 · EYB
Fossa Medical, Inc.
Gastroenterology & Urology · 36d