9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·May 19, 2021
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 10, 2013
SYR 100ML WITH HANDIFIL BX50
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·May 16, 2008
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
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