18 results · 32ms · Sources: EU EUDAMED, US FDA

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R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450090473·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450270929·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450220061·

CNS-9300 SERIES CENTRAL STATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

BALLERT CRANIAL MOLDING HELMET

FDA 510(k)
FDA Class 2 ·Neurology

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 18, 2025

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

PANORAMA CENTRAL STATION

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC·Product code MHX·April 30, 2013

SIGMA CRVD XLK INS 4 10MM

FDA Adverse Event
Injury ·DEPUY IRELAND 9616671·Product code JWH·September 16, 2014

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·May 17, 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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018