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

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    SINMED POSITIONING DEVICES

    FDA 510(k)
    FDA Class 2 ·Radiology

    SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COAXIAL DILATOR SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGATING DEVICE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FHN·March 29, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYB·June 11, 2008

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    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

    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