10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACEART SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LATEX SURGEONS GLOVE (POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019
BD INTEGRA¿ 3ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 10, 2015
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·March 27, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 18, 2011
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·March 27, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018