9 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
FDA 510(k)
FDA Class 2
·Cardiovascular
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
TWINTRODE ELC 134 ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 21, 2019
WHEELCHAIR ACCESSORY
FDA Adverse Event
NEW PROKIN·Product code INE·May 3, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·August 20, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011
CAP FOR INJECTOR MEMBRANE M50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021
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