12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MINIPHYSIONIZER 2.0 AND ELECTRODES
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRAL'S 2 IN 1 (TNI-MYO)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
LG HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·July 19, 2022
GENDEX 765 DC
FDA Adverse Event
Malfunction
·GENDES DENTAL SYSTEMS·Product code EHD·March 20, 2013
RESOLUTION II CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·March 18, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024