BEUDAMED
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    EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

    FDA 510(k)
    FDA Class 2 ·General Hospital

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

    LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

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

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 10, 2013

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT D

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code MEH·June 12, 2008

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 6, 2011

    STIMQ NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 14, 2021

    STIMQ NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 8, 2021

    FREEDOM NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 10, 2021

    FREEDOM NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·April 9, 2021

    STIMQ NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 15, 2021

    FREEDOM NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 7, 2021

    FREEDOM NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·April 7, 2021

    FREEDOM NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 24, 2021

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011