14 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PTA Balloon Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

CoRoent

FDA UDI
Nuvasive, Inc.·00887517287472·CoRoent® XL-CTW, 12x22x45mm, 10°

CoRoent

FDA UDI
Nuvasive, Inc.·00887517300164·CoRoent® XLK, 12x18x45mm 10°

InCompass®

FDA UDI
ZIMMER SPINE, INC.·00889024400535·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970386·

Vu aPod™ - L

FDA UDI
Seaspine Orthopedics Corporation·10889981046484·LATERAL TRIAL, WIDE, STANDARD, 12mm X 23mm X 45mm

Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning

FDA 510(k)
FDA Class 2 ·Neurology

DEGOTZEN SYNCHRO

FDA 510(k)
FDA Class 2 ·Dental

MECTALIF ANT - LAG

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 5, 2008

ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·COOK, INC.·Product code DQY·August 17, 2011

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 11, 2013

COPAN WASP/COLIBRI

FDA Adverse Event
Other ·COPAN WASP·Product code QQV·July 25, 2024

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026