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
166873–166896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1980
CATHETER STYLET
K800609 · KOD
G.D. Searle and Co.
Gastroenterology & Urology · 24d
Cleared Apr 10, 1980
BUN REAGENT KIT #88108
K800616 · CDS
Hi Chem, Inc.
Chemistry · 23d
Cleared Apr 10, 1980
KODAK EKTACHEM CLINICAL CHEM. SLIDES
K800628 · JGS
Eastman Kodak Company
Chemistry · 21d
Cleared Apr 10, 1980
C.C.-PAK
K800635 · JOL
Respiratory Care, Inc.
General Hospital · 20d
Cleared Apr 10, 1980
CENTRIFI CHEM AST/SGOT
K800641 · CIT
Union Carbide Corp.
Chemistry · 17d
Cleared Apr 10, 1980
AMES TDA THEOPHYL-LINE TEST
K800646 · KLS
Miles Laboratories, Inc.
Toxicology · 17d
Cleared Apr 10, 1980
T-570 TINNITUS MASKER
K800701 · KLW
Audiotrone
Ear, Nose, Throat · 13d
Cleared Apr 10, 1980
MJ PERCUSSOR
K800713 · BYI
Cussionair Therapy Products, Inc.
Anesthesiology · 10d
Cleared Apr 10, 1980
U-STYLE ADAPTER
K800735 · EGS
American Midwest
Dental · 8d
Cleared Apr 10, 1980
SNAP-WAY HEADGEAR
K800748 · DZB
Northwest Orthodontics, Inc.
Dental · 6d
Cleared Apr 10, 1980
TENZCARE DUAL-CHANNEL STIMULATOR
K800758 · GZJ
3M Company
Neurology · 6d
Cleared Apr 08, 1980
LOW PLASTICIZER ADMINISTRATION SETS
K791496 · FPA
Travenol Laboratories, S.A.
General Hospital · 249d
Cleared Apr 08, 1980
HEMODIALYSIS CONCENTRATE SOLUTION
K792513 · KPO
Mid Atlantic Nephrology Center
Gastroenterology & Urology · 125d
Cleared Apr 08, 1980
COMBISON COMPUTER
K800092 · DQK
Kt Medical, Inc.
Cardiovascular · 85d
Cleared Apr 08, 1980
WATER CONDUCTIVITY MONITOR & CONTROLLER
K800305 · FIP
Darco Water Systems, Inc.
Gastroenterology & Urology · 67d
Cleared Apr 08, 1980
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330 · FKP
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 55d
Cleared Apr 08, 1980
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
K800425 · FKP
Gambro, Inc.
Gastroenterology & Urology · 42d
Cleared Apr 08, 1980
RUDD-CLINIC HEMORRHOIDAL FORCEPS
K800441 · KOA
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 40d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149
K800446 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149HF
K800447 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 08, 1980
SUR-FIT UROSTOMY POUCH & URINARY BAG
K800495 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
PULSEOMETER
K800500 · DRT
Kirklands Sporting Goods Co.
Cardiovascular · 35d
Cleared Apr 08, 1980
URETHRAL CATHETER
K800505 · KOD
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
FEEDING TUBES
K800507 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d