10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
COBAS INTEGRA AMPHETAMINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
FDA 510(k)
FDA Class 2
·Anesthesiology
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·November 1, 2019
NEEDLE 25X5/8 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 4, 2020
ENDO SMARTCAP
FDA Adverse Event
MEDIVATORS·Product code KOG·February 2, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 6, 2013
PROTECTIV JELCO
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INC.·Product code FOZ·September 9, 2014
PSYCHEMEDICS HAIR TEST
FDA Adverse Event
Injury
·PSYCHEMEDIC CORP.·Product code DJG·May 13, 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