BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    MAC-LAB/CARDIOLAB EP/COMBOLAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854002629·ULTRAPOWER BUR, ROUND DIAMOND (LIME), 6 MM

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657063289·Biopsy Punch, 5mm with Tooth Handle: 1366 Stan...

    PROSTEC 125I BRANCHYTHERAPY SNAPSEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC)·Product code LMH·April 29, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·March 26, 2013

    EONC CONVENTIONAL IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 8, 2011

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018