BEUDAMED
    39 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ACQSIM-MULTISLICE-CT, MODEL 453567042271

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. 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 Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product 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·September 22, 2011

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033357·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

    QUANTIX/OR DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCPM 1050 RESIN-HIPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RINGLOC-X ARCOMXL H/W 50/32MM 23

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·May 10, 2016

    RINGLOC-X ARCOMXL H/W 54/36MM 24

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·July 1, 2016

    RINGLOC-X ARCOM LINER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·July 20, 2017

    RINGLOC-X E1 H/W 60/36MM 26

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·July 20, 2016

    RINGLOC-X E1 H/+3MM 50/36MM 23

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·February 1, 2016

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22)

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·July 29, 2016

    RINGLOC-X E1 H/W 60/36MM 26

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·July 20, 2016

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24)

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·April 20, 2016

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 46MM (RINGLOC SIZE 22)

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·July 29, 2016

    ARCPM 1050 RESIN-HIPS

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LPH·April 5, 2017

    E1 10DEG LINER RINGLOC-X 58MM

    FDA Adverse Event
    Malfunction ·.·Product code LPH·May 11, 2017

    RLOC-X E1 H/W +3MM 50/36MM 23

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2019

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 1, 2013

    SECURE 2 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 22, 2011