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

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T-PORT HP INFUSION PORT

FDA 510(k)
FDA Class 2 ·General Hospital

QUANTUM BLAST

FDA 510(k)
FDA Class 2 ·Physical Medicine

SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PROSPACE PEEK IMPLANT 5 7X8X22MM

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

TSPACE PEEK IMPLANT 26X11X7MM

FDA Adverse Event
Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
Malfunction ·INVAMEX·Product code ILS·April 22, 2013

GO BED PLUS

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 19, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50 44, CODE J

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·January 11, 2019

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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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