5 results · 11ms · Sources: EU EUDAMED, US FDA

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rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Enforcement
Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

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

MagNA Pure LC Instrument; Catalog number 2236931.

FDA Recall
Terminated ·Roche Diagnostics Corp.·May 27, 2003

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

FDA Enforcement
Class II ·Terminated·Cook Inc.·September 23, 2020

rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 26, 2015