10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
FDA 510(k)
FDA Class 2
·Anesthesiology
TOTAL O2
FDA 510(k)
FDA Class 2
·Anesthesiology
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 11, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 28, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 13, 2011
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023
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