13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
10-3031347 Protection Sheet 140
Device
EU MDR
·
Eu Md Class 1
·Ab Fatex Oy·On the market·3 countries
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MERIDIAN-II AND MERDIAN-PLUS
FDA 510(k)
FDA Class 2
·Neurology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 14, 2022
GPS STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·March 5, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 24, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 18, 2008
10-3031347 Protection Sheet 140cm
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Ab Fatex Oy·1 device
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