FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,622 results for "medtronic"
481–504 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · LIT
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 22, 2013
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA...
K123314 · DTZ
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Jan 10, 2013
AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
K123201 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 90d
Cleared Jan 10, 2013
MEDTRONIC XOMED, INC.
K122391 · LRK
Medtronic Xomed, Inc.
Dental · 156d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL...
K122914 · DTN
Medtronic, Inc.
Cardiovascular · 110d
Cleared Dec 27, 2012
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · DRA
Medtronic Cryocath, LP
Cardiovascular · 36d
Cleared Dec 21, 2012
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · HRX
Medtronic
Orthopedic · 14d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 14, 2012
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE...
K122827 · DTZ
Medtronic, Inc.
Cardiovascular · 91d
Cleared Dec 13, 2012
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY...
K123448 · DTL
Medtronic, Inc.
Cardiovascular · 35d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · DTM
Medtronic, Inc.
Cardiovascular · 88d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 15, 2012
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
K113380 · GEI
Medtronic, Inc.
General & Plastic Surgery · 365d
Cleared Nov 02, 2012
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878 · OCL
Medtronic, Inc.
Cardiovascular · 127d
Cleared Nov 02, 2012
EC 2.7 ENDOSCOPIC CUTTER
K120909 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 221d
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · NHB
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Oct 19, 2012
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
K122913 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Oct 12, 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811 · DTL
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 03, 2012
CD HORIZON SPINAL SYSTEM
K122862 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Sep 28, 2012
CD HORIZON SPINAL SYSTEM
K122433 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Sep 25, 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · DQY
Medtronic, Inc.
Cardiovascular · 155d
Cleared Sep 18, 2012
CLYDESDALE SPINAL SYSTEM
K122591 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d