15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULL TAB SQUEEZE FLUSH
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070979·MISS RELAX 140 OPEN TOE, SIZE M, CIPRIA, GRADUA...
REDI-SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
FDA 510(k)
FDA Class 2
·Hematology
S4C POLYAXIAL SCREW 3.5X12MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009
NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·July 20, 2022
NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·July 9, 2024
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 29, 2013
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·April 19, 2011
UNKNOWN ZIMMER TM REVERSE GLENOSPHERE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·July 3, 2008
NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 11, 2024
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 28, 2024
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