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"
241–264 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122 · FTL
Medtronic, Inc.
General & Plastic Surgery · 142d
Cleared May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · KRH
Medtronic
Cardiovascular · 29d
Cleared May 18, 2018
KYPHON HV-R Bone Cement
K180700 · NDN
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K180030 · FTL
Medtronic, Inc.
General & Plastic Surgery · 111d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855 · EOB
Medtronic Xomed, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Apr 18, 2018
VERTEX™ Reconstruction System
K180851 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Apr 12, 2018
Admiral Xtreme
K173515 · LIT
Medtronic Vascular
Cardiovascular · 149d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae Kit
K180456 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae and Introducer
K180453 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 08, 2018
CD HORIZON™ Spinal System
K173249 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 149d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Dec 29, 2017
Medtronic O-arm O2 Imaging System
K173664 · OWB
Medtronic, Inc.
Radiology · 30d
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · MQP
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Dec 20, 2017
Sentrant Introducer Sheath with Hydrophilic Coating
K171866 · DYB
Medtronic Vascular, Inc.
Cardiovascular · 181d
Cleared Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator...
K172984 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Nov 02, 2017
SOVEREIGN™ Spinal System
K172328 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 92d
Cleared Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short...
K162812 · FPA
Unomedical A/S
General Hospital · 391d
Cleared Oct 27, 2017
Tubing Pack
K171979 · DWF
Medtronic, Inc.
Cardiovascular · 119d
Cleared Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion...
K172626 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Oct 23, 2017
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · PML
Medtronic
Orthopedic · 117d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K171689 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d