12 results
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19ms
·
Sources: EU EUDAMED, US FDA
WAVE FLUORESCENT MAGNIFIER
FDA 510(k)
FDA Class 1
·General Hospital
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194789·Interbody, 9mm x 36mm x 8mm, 8 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202774·Interbody, 9mm x 36mm x 8mm, 8 deg
FST CATH UD-DUAL DUAL PRESSURE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORTRESS C-500 MICROPROCESSOR CONTROLLER
FDA 510(k)
FDA Class 2
·Physical Medicine
HUDSON VENTILATOR MONITORING ADAPTOR CIRCUIT
FDA Adverse Event
Injury
·TELEFLEX MEDICAL·Product code BZO·December 13, 2010
SYNERGY
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·January 30, 2013
MINIMAL ACCESS DRIVER,ANGLED
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 15, 2014
2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HWC·November 30, 2017
2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HWC·November 30, 2017
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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