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"
553–576 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
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 22, 2010
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
K103095 · LOX
Medtronic, Ireland
Cardiovascular · 14d
Cleared Oct 22, 2010
KYPHON ANCHOR FACET SCREW SYSTEM
K101765 · MRW
Medtronic Spine, LLC
Orthopedic · 121d
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Oct 14, 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · HRX
Medtronic
Orthopedic · 104d
Cleared Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · JOX
Medtronic, Inc.
Hematology · 160d
Cleared Sep 30, 2010
TSRH(R) SPINAL SYSTEM
K101772 · NKB
Medtronic Sofamor Danek
Orthopedic · 98d
Cleared Sep 27, 2010
CD HORIZON SPINAL SYSTEM
K091445 · NKB
Medtronic Sofamor Danek
Orthopedic · 500d
Cleared Sep 09, 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885 · DQY
Medtronic, Inc.
Cardiovascular · 65d
Cleared Sep 03, 2010
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED),...
K101186 · DTP
Medtronic Perfusion Systems
Cardiovascular · 128d
Cleared Sep 01, 2010
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH)...
K102176 · DRA
Medtronic Cryocath, LP
Cardiovascular · 29d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · DQX
Medtronic, Inc.
Cardiovascular · 111d