Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,631 results for "Medtronic"
265–288 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System,...
K172199 · MAX
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Sep 07, 2017
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
K170381 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 212d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031 · MAX
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared Jul 03, 2017
NavLock Trackers
K171267 · OLO
Medtronic Navigation
Orthopedic · 63d
Cleared Jun 16, 2017
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque...
K170191 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 13, 2017
FUSE Spinal System
K171468 · MAX
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Jun 13, 2017
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2017
Tubing Pack
K171308 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585 · LZO
Responsive Orthopedics, LLC
Orthopedic · 164d
Cleared May 25, 2017
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K171253 · LDF
Medtronic
Cardiovascular · 27d
Cleared May 19, 2017
StealthStationTM S8 ENT Software
K170018 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 136d
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared May 16, 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · KNT
Covidien (Dba Medtronic)
Gastroenterology & Urology · 200d