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

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    Merge Hemo, Model RCSV2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tecomet

    FDA UDI
    TECOMET INC.·00841435120112·MINI-TIP RONGEUR 40D

    VisionX 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONVERTBL I.V.DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011

    CONVERTBL I.V..DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·August 13, 2009

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012

    CONVERTBL I.V. DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    CONVERTBL I.V. DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·November 6, 2014

    APEX MONORAIL

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 2, 2011

    AMISTEM C FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·July 12, 2013

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 11, 2018

    Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·August 29, 2011

    Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·August 29, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device 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·November 11, 2011

    Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·September 6, 2011

    Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·September 6, 2011