8 results · 21ms · Sources: EU EUDAMED, US FDA

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ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOEMG II AND BIOJVA

FDA 510(k)
FDA Class 2 ·Physical Medicine

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

FDA 510(k)
FDA Class 2 ·Dental

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·April 9, 2013

IN TOUCH ZX

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 15, 2011

SELUTE PICOTIP LEAD

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018