9 results · 19ms · Sources: EU EUDAMED, US FDA

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CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZINC PHOSPHATE CEMENT

FDA 510(k)
FDA Class 2 ·Dental

ALIGN TO URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BARD SHANNON LTD·Product code FTL·January 31, 2012

TOTAL ASR FEM IMP SIZE 45

FDA Adverse Event
Injury ·DEPUY FRANCE SAS 3003895575·Product code KXA·March 27, 2013

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code LYJ·March 8, 2011

GUIDANT 4.3 MM AORTIC CUTTER

FDA Adverse Event
Injury ·GUIDANT CARDIAC SURGERY·Product code DXC·April 2, 2008

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·April 22, 2021

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