27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONALIS
FDA 510(k)
FDA Class 2
·Radiology
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
FDA 510(k)
FDA Class 2
·Physical Medicine
LISTER BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046467·LISTER BANDAGE SCISSORS
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120373·Guidewire 2.0x100mm Sgl Trocar
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948004786·DURAVENT 2 IC, SIZE 4
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869633505·MOSS Inserter Bone Screw
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 18, 2014
STRYKER NAVIGATION SYSTEM-KNEE MODULE
FDA 510(k)
FDA Class 2
·Neurology
WIN-1 TANGO
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 5, 2023
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 8, 2020
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·April 23, 2014
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·February 27, 2014
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·July 30, 2008
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 16, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·December 10, 2020
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
FDA Enforcement
Class II
·Terminated·Terumo Medical Corporation·July 31, 2019