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

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    3D Ceiling Suspension

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZF·April 15, 2003

    Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZF·February 10, 2020

    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 8, 2015

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 28, 2016

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016

    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·July 30, 2014

    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code MAX·May 21, 2015

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code GKA·September 14, 2004

    Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR

    FDA Recall
    Terminated ·Permobil, Ab Arvaltsvagen 10·Product code ITI·September 1, 2017

    Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR

    FDA Enforcement
    Class II ·Terminated·Permobil, Ab·October 11, 2017

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    FDA Recall
    Terminated ·DJO, LLC·Product code IMF·June 25, 2018

    Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019