10 results · 38ms · Sources: EU EUDAMED, US FDA

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LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000

FDA 510(k)
FDA Class 2 ·Anesthesiology

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

FDA Adverse Event
Malfunction ·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015

ARTICUL/EZE CER BALL 28 +1.5

FDA Adverse Event
Injury ·DEPUY (IRELAND) 9616671·Product code LZO·April 23, 2013

CAPSTONE SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MSD BARTLETT MFG·Product code MAX·April 29, 2011

SPRINT QUATTRO

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

NFLEX CURVED ROD 60MM-STERILE

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code NQP·March 31, 2016

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