BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    BIFIX SE

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 3, 2020

    SMART RAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRIALIT-2 ESTHETICBASE ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 5, 2013

    VA LOCKSCR 2.4 SELF-TAP L20 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·April 29, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·May 10, 2011

    LIVEWIRE SPIRAL HP CATHETER

    FDA Adverse Event
    Malfunction ·ST. JUDE CARDIOLOGY·Product code DRF·July 14, 2008

    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014