9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETOH FLEX REAGENT CARTRIDGE (DF22)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Acapella One
FDA UDI
Choice Spine, LP·00840996151443·ACAPELLA,TRIAL,CX,NS,14X18X11
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 22, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·April 28, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·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