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"
145–168 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544 · FPA
Unomedical A/S
Chemistry · 142d
Cleared Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
K201100 · DWF
Medtronic, Inc.
Cardiovascular · 447d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · DSA
Medtronic, Inc.
Cardiovascular · 217d
Cleared Jul 08, 2021
StealthStation Spinous Process Clamps
K211442 · OLO
Medtronic Navigation
Orthopedic · 59d
Cleared Jun 23, 2021
CD Horizon Spinal System
K211596 · OLO
Medtronic
Orthopedic · 30d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · MXD
Medtronic, Inc.
Cardiovascular · 112d
Cleared Jun 09, 2021
Navigated Anterolateral Disc Prep Instruments
K211441 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · MXD
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 27, 2021
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · OWI
Medtronic, Inc.
Orthopedic · 48d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System,...
K211258 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared Apr 30, 2021
CD Horizon™ Spinal System
K210637 · NKB
Medtronic
Orthopedic · 58d
Cleared Mar 18, 2021
Infinity™ OCT System, PASS OCT® Spinal System
K210449 · NKG
Medtronic
Orthopedic · 30d
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Medtronic Navigation, Inc.
Neurology · 30d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 08, 2020
Novapak Nasal Sinus Packing and Stent
K202623 · LYA
Medtronic Xomed
Ear, Nose, Throat · 89d
Cleared Nov 18, 2020
Pacific Plus PTA Catheter
K202800 · LIT
Medtronic Vascular,Inc(Formerly D.B.A...
Cardiovascular · 56d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620 · DRA
Medtronic Cryocath, LP
Cardiovascular · 64d
Cleared Nov 02, 2020
Midas Rex Attachments and Dissecting Tools
K202552 · OLO
Medtronic Powered Surgical Solutions...
Orthopedic · 60d
Cleared Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
K200759 · GWF
Medtronic Xomed, Inc.
Neurology · 218d
Cleared Oct 19, 2020
CD Horizon Spinal System
K202771 · NKB
Medtronic
Orthopedic · 28d
Cleared Oct 08, 2020
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
K193542 · KDI
Bellco Srl
Gastroenterology & Urology · 293d
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d