15 results · 20ms · Sources: EU EUDAMED, US FDA

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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