FDA 510(k) Regulatory Intelligence Search

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

175,218 clearances · 1976 to present · Updated monthly from FDA records

1,616 results for "Medtronic"
1009–1032 of 1,616
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 25, 2002
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
K014223 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · OCL
Medtronic Vascular
Cardiovascular · 102d
Cleared Jan 25, 2002
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K012937 · HAW
Medtronic Surgical Navigation...
Neurology · 147d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 11, 2001
GRIP LOCK ANCHOR, MODEL 411374
K013063 · GZB
Medtronic Neurological
Neurology · 90d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K013000 · GXN
Medtronic Neurosurgery
Neurology · 90d
Cleared Dec 04, 2001
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
K013013 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 88d
Cleared Dec 03, 2001
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
K011144 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 231d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579 · DQY
Medtronic Vascular
Cardiovascular · 267d
Cleared Oct 24, 2001
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · DRA
Medtronic Cardiac Surgical Products
Cardiovascular · 106d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 11, 2001
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
K011080 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 185d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 28, 2001
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K012428 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 59d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · DTM
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · DPT
Medtronic Perfusion Systems
Cardiovascular · 29d