19 results · 24ms · Sources: EU EUDAMED, US FDA

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GERDX-System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200

FDA 510(k)
FDA Class 2 ·Physical Medicine

VARIAN MULTILEAF COLLIMATOR

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 11, 2019

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 21, 2021

PLATE,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·May 26, 2017

PLATE,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·May 26, 2017

PLATE,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·May 26, 2017

ENDURANT STENT GRAFT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·August 10, 2020

ENDURANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·August 10, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 25, 2021

INGEVITY MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·December 14, 2022

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 6, 2014

JOSTENT ENDOSCOPIC STENT

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code FGE·September 2, 2011

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·July 18, 2013

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code HRS·April 9, 2015

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HRS·April 9, 2015

Philips Azurion system; Software Version Number: R3.1;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026