12 results
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60ms
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Sources: EU EUDAMED, US FDA
BINAXNOW INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
OLEEVA FOAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DRI ECSTASY URINE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CER BIOLOXD OPTION HD 40MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·September 2, 2025
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·Product code OYC·April 16, 2013
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 18, 2008
*
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·April 15, 2011
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022