11 results · 37ms · Sources: EU EUDAMED, US FDA

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GC MODELS OPA-100 AND JC-50

FDA 510(k)
FDA Class 2 ·Dental

PROFEMUR LX HIP STEM

FDA 510(k)
FDA Class 3 ·Orthopedic

MYLAB 15 / MYLAB 20, MODEL 2700

FDA 510(k)
FDA Class 2 ·Radiology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2022

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 23, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 27, 2011

RIATA ST ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

FDA Adverse Event
Injury ·COOK INC·Product code DTK·March 25, 2016

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·March 23, 2018

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