BEUDAMED
    22 results · 33ms · Sources: EU EUDAMED, US FDA

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    CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722312·Van Sickle Rake Retractor 6" (15cm), 4 blunt p...

    VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB

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

    EVERYWAY LOW BACK PAIN RELIEF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    VISAO BUR GUARD (DEVICE 3 OF 4)

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·October 23, 2008

    PRECISION OPTIUM EZ

    FDA Adverse Event
    Malfunction ·Product code NBW·August 12, 2011

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·October 23, 2020

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015