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

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176,076 results
166585–166608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1980
QUINTREX 0515 PROGRAMMABLE PULSE GEN.
K802223
Medcor, Inc.
Cardiovascular
Cleared Sep 12, 1980
QUINTREX 0516 PROG. PULSE GENERATOR SYS
K802224
Medcor, Inc.
Cardiovascular
Cleared Sep 10, 1980
STERILE DISPOSABLE CYTOLOGY BRUSH
K802187
Olympus Corp.
Gastroenterology & Urology
Cleared Sep 09, 1980
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 253d
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226 · DXY
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 09, 1980
VOCON MODEL VC526
K801314 · FSO
Teknar, Inc.
General & Plastic Surgery · 98d
Cleared Sep 09, 1980
CUFFED TRACHEA TUBE FOR USE W/PERTRACH
K801379 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 90d
Cleared Sep 09, 1980
ASSURE LEVEL I PROD. #30171
K801538 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ASSURE LEVEL II PROD. #30172
K801539 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ORTHO AUTOMATED CELL COUNTER
K801545 · GKL
Ortho Instruments
Hematology · 64d
Cleared Sep 09, 1980
TEST PANEL FOR PRESUMP. ID/BACT. ORG
K801547 · JSP
Micro-Media Systems, Inc.
Microbiology · 64d
Cleared Sep 09, 1980
SAPCRILL THERMODETECT BREAST SCANNER DEV
K801573 · KYZ
California Cardiac Systems, Inc.
General Hospital · 62d
Cleared Sep 09, 1980
ACE FISCHER EXTERNAL FIXATION DEVICE
K801594 · HXK
Ace Orthopedic Manufacturing Co.
Orthopedic · 57d
Cleared Sep 09, 1980
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K801621 · DSY
Impra, Inc.
Cardiovascular · 56d
Cleared Sep 09, 1980
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
K801659 · HJO
Coburn Optical Ind., Inc.
Ophthalmic · 50d
Cleared Sep 09, 1980
SUR-FIT SYSTEM STERILE O.R. SETS
K801703 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 09, 1980
HDL CHOLESTEROL TEST KIT
K801726 · LBS
Mallinckrodt Critical Care
Chemistry · 47d
Cleared Sep 09, 1980
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727 · CDL
Data Medical Associates, Inc.
Chemistry · 47d
Cleared Sep 09, 1980
FIELD-LEE BRAIN BIOPSY NEEDLE
K801760 · HAO
American V. Mueller
Neurology · 43d
Cleared Sep 09, 1980
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
K801806 · DXY
Arco Medical Products Co.
Cardiovascular · 41d
Cleared Sep 09, 1980
PALPATION ENHANCER
K801811 · LDE
Medical Horizons Co.
Cardiovascular · 63d
Cleared Sep 09, 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · DSI
Del Mar Avionics
Cardiovascular · 39d
Cleared Sep 09, 1980
SURGICAL BANDAGES/SUNLEEP DX
K801840 · NAD
Martin'S Maine Exchange
General & Plastic Surgery · 39d
Cleared Sep 09, 1980
ELECTROCARDIOGRAPH ELECTRODE
K801846 · DRX
Phoenix Glove Co.
Cardiovascular · 36d