3 results
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7ms
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Sources: EU EUDAMED, US FDA
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
FDA Enforcement
Class II
·Completed·Pintler Medical LLC·April 24, 2019
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
FDA Enforcement
Class II
·Completed·Materialise N.V.·July 26, 2023