12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINDE INTEGRATED VALVE (LIV)
FDA 510(k)
FDA Class 1
·Anesthesiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704289367·
GLOBALCARDIO
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
FDA 510(k)
FDA Class 2
·Anesthesiology
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 4, 2022
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FRN·March 27, 2013
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·June 19, 2008
M-4 120V W/PKS
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IRQ·September 23, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015