FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

1,626 results for "medtronic"
553–576 of 1,626
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA...
K111972 · KFM
Medtronic, Inc.
Cardiovascular · 16d
Cleared Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · MAX
Medtronic Sofamor Danek
Orthopedic · 208d
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 Jun 08, 2011
TSRH SPINAL SYSTEM
K110070 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 149d
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676 · NKB
Medtronic Sofamor Danek
Orthopedic · 74d
Cleared May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE...
K103764 · DSI
Medtronic, Inc.
Cardiovascular · 132d
Cleared Apr 13, 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 75d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Mar 18, 2011
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
K102588 · DRF
Medtronic Ablation Frontiers, LLC
Cardiovascular · 190d
Cleared Feb 28, 2011
KYPHON XPEDE BONE CEMENT
K102397 · NDN
Medtronic
Orthopedic · 188d
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R)...
K103386 · DQY
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Jan 24, 2011
KYPHON INFLATION SYRINGE
K103231 · HRX
Medtronic Spine, LLC
Orthopedic · 84d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049 · NKB
Medtronic Sofamor Danek
Orthopedic · 69d
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 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 269d
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