7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NUVASIVE HELIX ACP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·April 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011
REACH DENTAL FLOSS MINT WAXED
FDA Adverse Event
Injury
·JOHNSON & JOHNSON HEALTHCARE PRODUCTS·Product code JES·July 8, 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