24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONARCH IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
artegral
FDA UDI
Merz Dental GmbH·D7091970033·anteriors; shade A2; mould BL
LEONE SPA
FDA UDI
LEONE SPA·08033707087083·BANDE ANATOMICHE SMILE I MOL LL 33
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·T-SCAN 2000
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
FDA 510(k)
FDA Class 2
·Orthopedic
SPAC TM T3 UPTAKE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·TS2000
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·TRANSCAN T-SCAN 2000
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 28, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 20, 2013
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·January 14, 2011
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Injury
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 27, 2025