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
171481–171504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1978
ANALYZER-SUPPLEMENT, KINETIC, LKB 2086
K780461 · DLF
Syva Co.
Toxicology · 20d
Cleared Apr 12, 1978
INSTRUMENT AND ACCESSORY KIT
K780488 · KDD
American Hospital Supply Corp.
General & Plastic Surgery · 16d
Cleared Apr 12, 1978
SPINE BOARD
K780489 · IQF
Marullo, Baldwin, Frieden, Gatewood,
Physical Medicine · 16d
Cleared Apr 10, 1978
WELL TYPE GAMMA COUNTER
K771612 · JJJ
Actus, Inc.
Radiology · 230d
Cleared Apr 10, 1978
WELL TYPE GAMMA COUNTER
K771613 · JJJ
Actus, Inc.
Radiology · 230d
Cleared Apr 10, 1978
THERMOMETER, DIGITAL, NTM-100
K780131 · FLL
Wilton Webster Laboratories
General Hospital · 76d
Cleared Apr 10, 1978
INFANT VENTILATOR MODEL 100
K780188 · CBK
Sechrist Industries, Inc.
Anesthesiology · 63d
Cleared Apr 10, 1978
DILUTION SPIKE
K780209 · FMI
Sterling Drug, Inc.
General Hospital · 63d
Cleared Apr 10, 1978
EYESCOPE
K780215 · HLJ
Visual Methods, Inc.
Ophthalmic · 60d
Cleared Apr 10, 1978
HOOD, INFANT OXYGEN
K780220 · FOG
Shiley, Inc.
Anesthesiology · 59d
Cleared Apr 10, 1978
PARENTERAL INFUSION CONTROLLER
K780223 · FLN
Travenol Laboratories, S.A.
General Hospital · 60d
Cleared Apr 10, 1978
ICE-PAK, PDI
K780279 · IMD
Nice-Pak Products, Inc.
Physical Medicine · 48d
Cleared Apr 10, 1978
SPECTROPHOTOMETERS
K780342 · JXR
The Perkin-Elmer Corp.
Chemistry · 39d
Cleared Apr 10, 1978
STAND UP TOILET
K780370 · FOB
Medical Specialty Products, Inc.
General Hospital · 34d
Cleared Apr 10, 1978
TILT TYPE AC POWERED HOSPITAL BED
K780371 · FNL
Medical Specialty Products, Inc.
General Hospital · 34d
Cleared Apr 10, 1978
GAUZE FLUFF
K780394 · NAB
The Torrent Corp.
General & Plastic Surgery · 28d
Cleared Apr 10, 1978
2C7125 BLOW BOTTLE
K780407 · BYO
Travenol Laboratories, S.A.
Anesthesiology · 28d
Cleared Apr 10, 1978
OCTOPUS
K780414 · HPT
Hitron Corp.
Ophthalmic · 26d
Cleared Apr 10, 1978
VIVONEX DELIVERY SYSTEM
K780415 · FPD
Norwich Pharmacal Co.
Gastroenterology & Urology · 27d
Cleared Apr 10, 1978
BURN DRESSING PAD
K780418 · FPY
The Owenby Co.
General & Plastic Surgery · 27d
Cleared Apr 10, 1978
CHAMBER, AEROBIC
K780440 · JTW
Marion Laboratories, Inc.
Microbiology · 21d
Cleared Apr 10, 1978
PANORAMIC X-RAY, DENTAL
K780469 · EHD
Den-Tal-Ez Mfg Co., Inc.
Radiology · 19d
Cleared Apr 10, 1978
I.V. LEVER CLAMP
K780481 · FPA
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Apr 10, 1978
NEIA-FERRITIN ENZYMEIMMUNOASSAY
K780490 · DBF
New England Immunology Assoc.
Immunology · 14d