10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Barco
FDA UDI
Barco NV·05415334001831·MDSC-8358 MNA
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 16, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015