BEUDAMED
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    UNIMED DISPOSABLE BLOOD PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574299·CoRoent Ant TLIF Ti, 12x10x36mm 4°

    PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 10, 2011

    CAREASSIST

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·August 14, 2008

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020

    IMPACTOR

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code HSB·February 26, 2020

    SLOTTED MALLET ADAPTOR

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code HSB·February 26, 2020

    NAIL ATTACHMENT ROD

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code HSB·February 26, 2020

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    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