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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
146785–146808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1985
COMPAS 1
K853209 · DSI
Cardiac Care Units, Inc.
Cardiovascular · 97d
Cleared Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K853239 · KFF
Haemachem, Inc.
Hematology · 96d
Cleared Nov 05, 1985
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI
K853253 · KNT
Corpak Co.
Gastroenterology & Urology · 95d
Cleared Nov 05, 1985
MULTIPLE
K853297 · ISA
Sun Air, Inc.
Physical Medicine · 91d
Cleared Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 89d
Cleared Nov 05, 1985
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 05, 1985
THE MOVER
K853424 · IOR
Invacare Corp.
Physical Medicine · 83d
Cleared Nov 05, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518 · DTB
Intermedics, Inc.
Cardiovascular · 75d
Cleared Nov 05, 1985
POWER DRIVE WHEELCHAIR
K853649 · ITI
Everest & Jennings, Inc.
Physical Medicine · 63d
Cleared Nov 05, 1985
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666 · FGE
E-Z-Em, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 05, 1985
INFUSION CATHETER
K853997 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
GUIDE WIRE
K853999 · DQX
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
INFUSION CATHETER W/SIDE HOLES
K854000 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
RENALFO HEMOFILTER CAVHD
K854011 · KDI
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared Nov 05, 1985
COULTER COUNTER MODEL T-660
K854114 · GKL
Coulter Electronics, Inc.
Hematology · 28d
Cleared Nov 05, 1985
DEMAND ETHYL ALCOHOL
K854130 · DIC
Cooper Biomedical, Inc.
Chemistry · 27d
Cleared Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · KHG
Eastman Kodak Company
Hematology · 26d
Cleared Nov 05, 1985
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152 · CDT
Technicon Instruments Corp.
Chemistry · 25d
Cleared Nov 05, 1985
SUR-FIT FACE MASK
K854161 · BSJ
Anesthesia Respiratory Technology, Inc.
Anesthesiology · 25d
Cleared Nov 05, 1985
TDX COCAINE METABOLITE
K854163 · DIO
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
TDX PHENCYCLIDINE
K854167 · LCM
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
ASA BLOOD TUBING LINES
K854271 · FJK
Organon Teknika Corp.
Gastroenterology & Urology · 13d
Cleared Nov 04, 1985
VERSABLADE
K852633 · HNN
Alphamedix, Inc.
Ophthalmic · 137d
Cleared Nov 04, 1985
VERSABLADE
K852706 · HNN
Alphamedix, Inc.
Ophthalmic · 131d