8 results · 18ms · Sources: EU EUDAMED, US FDA

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VERTEBRON PSS PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOMATOM SMILE

FDA 510(k)
FDA Class 2 ·Radiology

ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2013

GENESIS DUAL HEADER IPG

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 24, 2011

VITALITY VR

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

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

Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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