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

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THE CROSSER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO PROFILE -II

FDA 510(k)
FDA Unclassified ·Unknown

DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

LINEAR 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 3, 2021

DAILIES TOTAL 1

FDA Adverse Event
CIBA VISION GMBH·Product code MVN·February 8, 2013

UNKNOWN

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 29, 2011

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

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