Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167713–167736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1980
S.K. DIAG. ULTRASND. SMALL PARTS SCAN
K800531 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Apr 10, 1980
S.K. DIAG. ULTRASOUND BODY SCANNER
K800532 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Apr 10, 1980
MODEL TRIEX-L HOLLOW FIBER DIALYZER
K800549 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 31d
Cleared Apr 10, 1980
MULTI-FORMAT SFD MODEL 1720
K800554 · IXL
Philips Medical Systems (Cleveland),...
Radiology · 29d
Cleared Apr 10, 1980
HYDRAGAMMA 16
K800601 · JJJ
Innotron of Oregon, Inc.
Chemistry · 24d
Cleared Apr 10, 1980
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · JJT
Beckman Instruments, Inc.
Chemistry · 24d
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