36 results · 21ms · Sources: EU EUDAMED, US FDA

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Invacare Platinum 5NXG Oxygen Concentrator

FDA 510(k)
FDA Class 2 ·Anesthesiology

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)

Responsive Respiratory

FDA UDI
RESPONSIVE RESPIRATORY, INC.·00851440007728·Adult Nebulizer Kit w/ Mouthpiece

UNIVERSAL NEURO 2

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154750566·LOW PROFILE PLATE, WITH TAB

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM

KARL STORZ MODEL 203210 O1 UNIMAT PLUS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SEEDLINKS, MODELS 70301, 70302, 70303

FDA 510(k)
FDA Class 2 ·Radiology

TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS

FDA 510(k)
FDA Class 2 ·General Hospital

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 16, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 14, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 9, 2008

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

TOTAL ASR ACET IMP SIZE 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 2, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC, INC.·Product code LWS·July 17, 2012

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 14, 2021

CAPSUREFIX NOVUS LEAD MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DTB·August 12, 2024

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·August 11, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·August 11, 2020