BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    SER-TEX

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    HEARTLINE RETRACTOR BLADES

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896095786·HEARTLINE RETRACTOR BLADES ATRIAL SOLID

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right

    ACUMED

    FDA UDI
    Acumed LLC·10806378045127·Trial Olecranon Plates Bend Template

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NWX·July 5, 2022

    VINTAGE ART

    FDA 510(k)
    FDA Class 2 ·Dental

    CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO

    FDA 510(k)
    FDA Class 1 ·Dental

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 10, 1998

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 10, 1998

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 10, 1998

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012

    PFC CVD 8MM SZ4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017