27 results · 22ms · Sources: EU EUDAMED, 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