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

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IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

MIZAR, BASIS BE, SANDMAN DIGITAL

FDA 510(k)
FDA Class 2 ·Neurology

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ADVANTAGE BALLOON CATHETER INFLATION DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MAV·April 2, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2014

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

FDA Adverse Event
Injury ·CYTYC SURGICAL PRODUCTS·Product code MNB·April 16, 2008

Spirit One A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

Spirit One A-C Powered Hospital Bed

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