9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROMED TOTAL REGULAR AND PARTIAL OFFSET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 3, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·July 18, 2014
SYNGO RT THERAPIST
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC., RADIOLOGY ONCOLOGY·Product code IYE·December 28, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. 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