27 results · 30ms · Sources: EU EUDAMED, US FDA

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ExcelsiusGPS Cranial 1.0 Module

FDA 510(k)
FDA Class 2 ·Neurology

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889975·PLATE 7200047 ATL VISION ELITE 47.5MM

ReLine

FDA UDI
Nuvasive, Inc.·00195377047304·RELINE-O Trial, 11mm H TP W L-pop

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994625335·PLATE 7200047 ATL VISION ELITE 47.5MM

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040187470·ZIRLUX ML DISC A2 98x14 Ea

POTTS SMITH FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059443·POTTS SMITH TISSUE FORCEPS TUNGSTEN CARBIDE SER...

24M - Memphis Light & Gas - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588000077·24M - Memphis Light & Gas - Metal

RUBICOR BREAST BIOPSY DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SUREFIT DUAL DISPERSIVE ELECTRODE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EVIS EXERA III XENON LIGHT SOURCE

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code NWB·December 8, 2025

FUSION QUATTRO EXTRACTION BALLOON

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024

AXIUM 3-D DETACHABLE COIL

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code HCG·October 15, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

FEMORAL COMPONENT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JDH·October 24, 2014

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 30, 2019

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 30, 2019

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 30, 2019

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 30, 2019

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 24, 2022

Brilliance iCT SP Computed Tomography X-ray system

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015