9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DRUG OF ABUSE ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
V-GO INSULIN DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010
LOANER SYS 7 DUAL TRIGGER ROTY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 30, 2014
ACCU-CHEK ® MULTICLIX LANCETS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code FMK·November 20, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·January 4, 2013
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
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