BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNTHES MANDIBLE EXTERNAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN

    FDA 510(k)
    FDA Class 1 ·Dental

    NAMILON POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI200401690·NAMILON POWDER 1 OZ SHADE 69

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400401690·C & B FORMULA 1 OZ SHADE 69

    PYROPLAST POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI100401690·PYROPLAST POWDER 1 OZ SHADE 69

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    KIT FLU A+B 30 TEST HOSPITAL VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·July 20, 2021

    VERSATILE RANGE FILL COIL (VFC)

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code HCG·April 3, 2013

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 5, 2011

    8010042-2008-00053

    FDA Adverse Event
    Death ·Product code CBK·May 2, 2008

    BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·August 3, 2021

    BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·August 3, 2021

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018