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"
361–384 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · HAW
Medtronic Navigation, Inc.
Neurology · 132d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared May 27, 2015
Intersept Filtered Cardiotomy Reservoir
K151110 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared May 27, 2015
Medtronic Patient Asistant
K150117 · DSI
Medtronic, Inc.
Cardiovascular · 127d
Cleared May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
K142648 · LLZ
Medtronic Sofamor Danek USA, Inc.
Radiology · 247d
Cleared May 21, 2015
PlasmaBlade UPPP and Suction Coagulator
K150297 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 104d
Cleared May 19, 2015
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink...
K151236 · PJT
Medtronic Minimed, Inc.
Chemistry · 8d
Cleared May 08, 2015
Level Sensor, Level Sensor Tape
K150530 · DTW
Medtronic, Inc.
Cardiovascular · 67d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · NDN
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d
Cleared Apr 09, 2015
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K150567 · DWF
Medtronic, Inc.
Cardiovascular · 34d
Cleared Apr 08, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K143019 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 170d
Cleared Apr 02, 2015
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · LOX
Medtronic, Inc.
Cardiovascular · 115d
Cleared Mar 27, 2015
TYRX Neuro Absorbable Antibacterial Envelope
K150291 · FTL
Medtronic Tyrx, Inc.
General & Plastic Surgery · 49d
Cleared Mar 25, 2015
Bio-Medicus Pediatric Cannula and Introducers
K143083 · DWF
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 25, 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K143073 · DTZ
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER,...
K141833 · HAW
Medtronic Navigation, Inc.
Neurology · 261d
Cleared Mar 20, 2015
EOPA 3D Arterial Cannula
K150422 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Mar 20, 2015
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K142344 · HAW
Izi Medical Products, LLC
Neurology · 210d
Cleared Mar 11, 2015
Attain Hybrid Guide Wire
K143316 · DQX
Medtronic, Inc.
Cardiovascular · 112d
Cleared Feb 25, 2015
CD HORIZON Growth Rod Conversion Set
K150200 · PGM
Medtronic Sofamor Danek USA,...
Orthopedic · 27d
Cleared Feb 18, 2015
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Feb 13, 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 80d