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

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CONTURA LUMEN MARKER

FDA 510(k)
FDA Class 2 ·Radiology

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

FDA 510(k)
FDA Class 2 ·Cardiovascular

BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

QUADRA H FEMORAL STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·February 13, 2012

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013

COLLEAGUE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 9, 2011

CD HORIZON AGILE SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPAEDIC INC.·Product code NQP·July 24, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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