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"
625–648 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 09, 2008
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE...
K080428 · DQY
Medtronic, Inc.
Cardiovascular · 294d
Cleared Dec 04, 2008
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
K082670 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002 · MQV
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Nov 21, 2008
TSRH SPINAL SYSTEM
K081080 · NKB
Medtronic Sofamor Danek
Orthopedic · 219d
Cleared Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY,...
K083076 · JXG
Medtronic Neurosurgery
Neurology · 35d
Cleared Nov 14, 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 10, 2008
PROGENIX
K082463 · NUN
Medtronic Sofamor Danek
Dental · 75d
Cleared Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC...
K082475 · DSI
Medtronic, Inc.
Cardiovascular · 71d
Cleared Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
K082464 · KNS
Medtronic, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 17, 2008
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM,...
K081475 · HBE
Medtronic Xomed, Inc.
Neurology · 143d
Cleared Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Oct 10, 2008
CD HORIZON SPINAL SYSTEM
K082236 · NKB
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Sep 17, 2008
MASTERGRAFT PUTTY
K081784 · LYC
Medtronic Sofamor Danek
Dental · 85d
Cleared Sep 12, 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · MAX
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 123d
Cleared Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · JXG
Medtronic Neurosurgery
Neurology · 29d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Aug 15, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · KWQ
Medtronic Sofamor Danek
Orthopedic · 126d
Cleared Aug 05, 2008
PIONEER PLUS CATHETER
K081804 · PDU
Medtronic, Inc.
Cardiovascular · 40d
Cleared Aug 01, 2008
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · NFA
Medtronic, Inc.
Cardiovascular · 231d
Cleared Jul 18, 2008
PROGENIX PLUS
K081950 · NUN
Medtronic Sofamor Danek, Inc.
Dental · 9d
Cleared Jul 18, 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · LLZ
Medtronic Navigation, Inc.
Radiology · 49d
Cleared Jun 27, 2008
MEDTRONIC EXPORT AP CATHETER
K081573 · DXE
Medtronic Vascular
Cardiovascular · 22d
Cleared Jun 16, 2008
AXIS FIXATION SYSTEM
K062254 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 682d