10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150652·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 200mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127021558·Offset Cup Impactor
Physica PS Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
FDA 510(k)
FDA Class 2
·Physical Medicine
LINER AND SHELL WITH PLASTIC BARRIER 40 MM I.D. 50 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MRA·March 9, 2021
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·February 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 7, 2011
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 15, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024