123 results · 18ms · Sources: EU EUDAMED, US FDA

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Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

FDA Recall
Terminated ·QLT USA, Inc.·Product code LYC·January 26, 2006

Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

FDA Recall
Terminated ·Zimmer, Inc.·Product code KWT·May 12, 2012

Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.

FDA Recall
Terminated ·Biomet, Inc.·Product code HWT·February 12, 2008

Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

FDA Recall
Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.

FDA Recall
Terminated ·Zimmer Inc.·Product code KWT·July 20, 2006

OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWT·March 9, 2005

00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

FDA Recall
Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010

Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

FDA Recall
Terminated ·Zimmer, Inc.·Product code HWT·October 10, 2010