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"
193–216 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
K192502 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
K193011 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Nov 25, 2019
VS3-IR
K191851 · OWN
Medtronic
General & Plastic Surgery · 138d
Cleared Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 86d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Medtronic Navigation, Inc.
Neurology · 137d
Cleared Oct 15, 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 197d
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · OCL
Medtronic, Inc.
Cardiovascular · 113d
Cleared Sep 27, 2019
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with...
K191444 · DTZ
Medtronic, Inc.
Cardiovascular · 119d
Cleared Sep 24, 2019
Patient Assistant Model PA97000
K190574 · DSI
Medtronic, Inc.
Cardiovascular · 202d
Cleared Sep 20, 2019
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™...
K191148 · PML
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 135d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Aug 08, 2019
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K190716 · LDF
Medtronic
Cardiovascular · 142d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Medtronic Navigation, Inc.
Neurology · 138d
Cleared Jul 30, 2019
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K190132 · DRF
Medtronic
Cardiovascular · 183d
Cleared Jul 30, 2019
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...
K183547 · DRF
Medtronic
Cardiovascular · 222d
Cleared Jul 26, 2019
Medtronic Total Hip Arthroplasty System
K183129 · LPH
Medtronic Advanced Energy
Orthopedic · 255d
Cleared Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K190959 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 82d
Cleared May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...
K190623 · OCL
Medtronic
Cardiovascular · 80d
Cleared May 22, 2019
Stealth-Midas MR8 System
K183644 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 147d
Cleared May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
K191029 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515 · HBC
Medtronic Powered Surgical Solutions
Neurology · 145d