15 results
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80ms
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Sources: EU EUDAMED, US FDA
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·April 7, 2025
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 27, 2022
SINGLE LUMEN PRESSURE MONITORING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·April 14, 2020
UNKNOWN MECHANICAL HEART VALVE
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code LWQ·March 15, 2024
HANDLE FOR HOOK OR SCREW HOLDER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·March 5, 2014
St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501
FDA Recall
Terminated
·St. Francis Medical Technologies Inc·Product code NQO·June 6, 2006
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
FDA Recall
Terminated
·Synvasive Technology Inc·Product code GFA·April 2, 2013
MediMark Europe Sarl.
Authorized representative
🇫🇷 France·35 Manufacturers·3394 Devices
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Kingsmead Service B.V.
Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices