15 results
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20ms
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Sources: EU EUDAMED, US FDA
EBICE
FDA 510(k)
FDA Class 2
·Physical Medicine
DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 7, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 12, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 14, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 27, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 10, 2021
SYNVISC ONE (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·January 31, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 3, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 18, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 28, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 28, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 18, 2020
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013