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

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WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

FDA Recall
Terminated ·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019

WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

FDA Recall
Terminated ·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019

BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code OLO·July 18, 2016

MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 18, 2016

FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code DZE·July 18, 2016

stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

FDA Recall
Open, Classified ·Wright Medical Technology, Inc.·Product code KWI·August 3, 2022

LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

BostonSight SCLERAL Lens

FDA Recall
Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013