8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GEOSOURCE
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450325063·
SYNTHES RESORBABLE CONTOURABLE MESH
FDA 510(k)
FDA Class 2
·Dental
MAROSIS PACS
FDA 510(k)
FDA Class 2
·Radiology
HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SILICON VALLEY·Product code GEX·May 5, 2011
ONE TOUCH BASIC METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 31, 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