3 results
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54ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries
FDA Recall
Terminated
·W & H DentalWerk Buermoos GMBH 53 Ignaz-Glazer-Strasse Burmoos Austria·Product code HWE·May 24, 2011
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
FDA Enforcement
Class II
·Terminated·W & H DentalWerk Burmoos GMBH - Site 1·April 18, 2018
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
FDA Recall
Terminated
·W & H DentalWerk Burmoos GMBH Site 1 Ignaz-Glaser-Strasse 53 Burmoos Austria·Product code EBW·December 21, 2017