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Materialise USA LLC

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to recall (Z-0418-2015)Materialise USA LLC2014-11-21
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET recall (Z-0628-2014)Materialise USA LLC2014-01-03
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specifi recall (Z-0577-2014)Materialise USA LLC2013-12-26
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specifi recall (Z-0578-2014)Materialise USA LLC2013-12-26
PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE ST recall (Z-1543-2012)Materialise USA LLC2012-05-14
PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE ST recall (Z-1544-2012)Materialise USA LLC2012-05-14

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Every clearance here is in the API, with alerts when new ones post.