8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
FACTS HAND AND PINCH GRIP COMBO
FDA 510(k)
FDA Class 2
·Orthopedic
MIZAR, BASIS BE, SANDMAN DIGITAL
FDA 510(k)
FDA Class 2
·Neurology
MARK II/MARK III MANOMETRIC PERFUSION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 28, 2024
COBAS 6000 C501 MODULE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code JJE·April 23, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2011
PROMOTE RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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