BEUDAMED
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    PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

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

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1203330·

    FIAB SPA, MODELS F7244, F7233, F7234, F7277

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

    ATRION MEDICAL QL FLUID DISPENSING SYRINGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINOX SMART SD 60/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·May 20, 2013

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·September 26, 2014

    AUTOLOG

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code CAC·May 27, 2011

    ENDURANCE CALCAR SZ3 145MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC·Product code JDI·April 4, 2013

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·March 27, 2013

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·March 27, 2013

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

    FDA Adverse Event
    Injury ·FIAB SPA·Product code GEI·October 12, 2023

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024