FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

1,611 results for "Medtronic"
529–552 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 26, 2011
IPC POWEREASE SYSTEM
K111520 · HBE
Medtronic Xomed, Inc.
Neurology · 146d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 12, 2011
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
K111264 · ODP
Medtronic Sofamor Danek USA
Orthopedic · 161d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · NKB
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX
Medtronic Sofamor Danek
Orthopedic · 84d
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