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

221 results for "medtronic, inc."
169–192 of 221
Search insights Median review: 70d Cleared: 100% Top manufacturer: Medtronic, Inc. Lead specialty: Cardiovascular
Cleared Jun 06, 2012
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
K120987 · DWF
Medtronic, Inc.
Cardiovascular · 65d
Cleared May 25, 2012
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · DWF
Medtronic, Inc.
Cardiovascular · 86d
Cleared May 22, 2012
AMPHIRION PLUS PTA CATHETER
K121265 · LIT
Medtronic, Inc.
Cardiovascular · 26d
Cleared May 10, 2012
AQUAMANTYS3 9.5 XL BIPOLAR SEALER
K120537 · GEI
Medtronic, Inc.
General & Plastic Surgery · 78d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · DTL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · DXS
Medtronic, Inc.
Cardiovascular · 30d
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART...
K112917 · DQY
Medtronic, Inc.
Cardiovascular · 24d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA...
K111972 · KFM
Medtronic, Inc.
Cardiovascular · 16d
Cleared Jun 28, 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · KFM
Medtronic, Inc.
Cardiovascular · 14d
Cleared Jun 23, 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · KFM
Medtronic, Inc.
Cardiovascular · 9d
Cleared Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · JOX
Medtronic, Inc.
Hematology · 27d
Cleared Jun 08, 2011
PACEART OPTIMA SYSTEM SOFTWARE
K110693 · KRE
Medtronic, Inc.
Cardiovascular · 89d
Cleared CT May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE...
K103764 · DSI
Medtronic, Inc.
Cardiovascular · 132d
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R)...
K103386 · DQY
Medtronic, Inc.
Cardiovascular · 85d
Cleared Dec 22, 2010
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 16, 2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · DTM
Medtronic, Inc.
Cardiovascular · 286d
Cleared Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · GGN
Medtronic, Inc.
Hematology · 23d
Cleared Dec 01, 2010
HEPARIN ASSAY CONTROLS
K103313 · GGN
Medtronic, Inc.
Hematology · 21d
Cleared Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · JOX
Medtronic, Inc.
Hematology · 31d
Cleared Oct 26, 2010
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · GZB
Medtronic, Inc.
Neurology · 54d
Cleared Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · JOX
Medtronic, Inc.
Hematology · 160d
Cleared Sep 09, 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885 · DQY
Medtronic, Inc.
Cardiovascular · 65d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · DQX
Medtronic, Inc.
Cardiovascular · 111d
Cleared Aug 12, 2010
KYPH X HV-R BONE CEMENT
K093828 · NDN
Medtronic, Inc.
Orthopedic · 241d