6 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Enforcement
Class II
·Completed·Materialise USA LLC·August 31, 2022
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·January 15, 2014
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·January 1, 2014
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·January 1, 2014
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·June 15, 2016
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·December 3, 2014