10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Recall
Terminated
·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code JWH·February 4, 2015
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2015
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·November 4, 2015
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2020
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2020
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·September 2, 2020
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code KWS·July 17, 2020
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
FDA Recall
Terminated
·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code OSF·September 23, 2015
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020