22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·April 16, 2019
LIFECARD CF 7 DAY
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
LUMAX 340 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code MRM·March 26, 2013
NOVOFINE 6MM (31G) (NEEDLE) NA
FDA Adverse Event
Other
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMI·March 7, 2011
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 28, 2008
SORIN BIOMEDICA SMARXT BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 16, 2016
MUSC CHARLESTON SC 1
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 27, 2023
SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·December 15, 2023
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 2, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·February 3, 2021
SORIN BIOMEDICA SMARXT BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019
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