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