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
69625–69648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 26, 2003
NXSTAGE PUREFLOW SOLUTION
K033386 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH...
K033411 · KTT
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Nov 25, 2003
CAPHOSOL
K030802 · LFD
Inpharma A.S.
Dental · 257d
Cleared Nov 25, 2003
MONITOR, MODEL HSM-00200
K031153 · DPW
Arrow Intl., Inc.
Cardiovascular · 228d
Cleared Nov 25, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL,...
K031340 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 211d
Cleared Nov 25, 2003
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
K031722 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 175d