17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEMINI IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189706·LEVAMED ACTIVE ANKLE SUP BLACK L I
NICOLET VERSALAB
FDA 510(k)
FDA Class 2
·Radiology
DISPO-MED 7.6 LITER SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·March 20, 2013
LIFECATH 1.9FR, PICC
FDA Adverse Event
Malfunction
·VYGON·Product code LJS·February 3, 2011
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NKE·March 10, 2008
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019
Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 7, 2018
ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020
ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025
ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025
ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023
ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025
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