12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
FDA 510(k)
FDA Class 2
·General Hospital
10 ML BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 7, 2017
MODIFICATION TO CENTAUR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
FDA 510(k)
FDA Class 2
·Anesthesiology
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 21, 2011
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Death
·CR. BARD, INC. (BASD)·Product code KNT·April 17, 2008
SUPER TURBOVAC 90 ICW
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·December 27, 2019
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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016