10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREFORMANCE POSTS AND TEMPORARY CYLINDERS
FDA 510(k)
FDA Class 2
·Dental
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES CERVIFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·April 16, 2013
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·June 16, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 5, 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