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"
577–600 of 1,611
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · HBB
Medtronic Sofamor Danek
Neurology · 120d
Cleared Aug 12, 2010
KYPH X HV-R BONE CEMENT
K093828 · NDN
Medtronic, Inc.
Orthopedic · 241d
Cleared Aug 07, 2010
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · KRH
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 23, 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · PDU
Medtronic Vascular
Cardiovascular · 28d
Cleared Jul 09, 2010
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L...
K100432 · FPA
Medtronic Minimed
General Hospital · 143d
Cleared Jun 30, 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · OVE
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Jun 25, 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · ODP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · KFM
Medtronic, Inc.
Cardiovascular · 109d
Cleared Jun 17, 2010
O-ARM IMAGING SYSTEM
K092564 · OXO
Medtronic Navigation, Inc. (Littleton)
Radiology · 301d
Cleared Jun 02, 2010
CLYDESDALE SPINAL SYSTEM
K100175 · MAX
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139 · KNS
Medtronic, Inc.
Gastroenterology & Urology · 29d
Cleared May 10, 2010
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L...
K100274 · DWF
Medtronic, Inc.
Cardiovascular · 101d
Cleared Apr 30, 2010
TSRH SPINAL SYSTEM
K091797 · NKB
Medtronic Sofamor Danek
Orthopedic · 317d
Cleared Apr 26, 2010
CRESCENT SPINAL SYSTEM
K094025 · MAX
Medtronic Sofamor Danek
Orthopedic · 117d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470 · DQX
Medtronic, Inc.
Cardiovascular · 62d
Cleared Mar 22, 2010
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · CAC
Medtronic, Inc.
Anesthesiology · 126d
Cleared Mar 16, 2010
POLESTAR, MODEL N-30
K092308 · LNH
Medtronic Navigation Israel, Ltd.
Radiology · 229d
Cleared Feb 26, 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831,...
K093203 · GEI
Medtronic, Inc.
General & Plastic Surgery · 136d
Cleared Feb 17, 2010
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
K093650 · DTY
Medtronic, Inc.
Cardiovascular · 84d
Cleared Dec 30, 2009
MEDTRONIC DENTAL TCP
K092087 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 174d
Cleared Dec 15, 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · DQX
Medtronic Vascular
Cardiovascular · 185d
Cleared Dec 02, 2009
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
K093434 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d