10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032153·Baltic Denture System BDLoad ↓ Sw7 PLSEum6DFs A...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20321531·BioFinisher wires Straight-Arch-F. mand. .021"x...
ULTRASONIC NEBULIZER, MODEL NE-520
FDA 510(k)
FDA Class 2
·Anesthesiology
LOWSLEY SUPRAPUBIC TRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·March 6, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 28, 2011
SANARUS VISICA 2 ICE PROBE
FDA Adverse Event
Injury
·SANARUS MEDICAL, INC.·Product code GEH·April 21, 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