9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032554·Baltic Denture System BDLoad Mw7 PLSEbim6DFm C4...
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SIGMA PS CEM FEM SZ4N R
FDA Adverse Event
Injury
·DEPUY INTL., LTD. 8010379·Product code JWH·April 3, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 29, 2011
8030916-2008-00012
FDA Adverse Event
Other
·Product code KME·April 14, 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 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