16 results · 22ms · Sources: EU EUDAMED, US FDA

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SilverStream Gel

FDA 510(k)
FDA Unclassified ·Unknown

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964096952·Endo Carry-On Procedure Kit

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964095429·Endo Carry-On Procedure Kit

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

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

ADVANTA SST BIFURCATED GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

AUVON TENS & EMS DEVICE

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

KINETRA

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007

DEEP BRAIN STIMULATION

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007

DEEP BRAIN STIMULATION LEAD

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 12, 2007

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

ETS FLEX ARTICNG

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2011

DEPUY ASR XL FEM IMP SIZE 39

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 1, 2013

AUVON TENS UNIT

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

1823260-2017-01577

FDA Adverse Event
Malfunction ·August 1, 2017

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

FDA Enforcement
Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016