46 results · 23ms · Sources: EU EUDAMED, US FDA

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VIAPEEL PEELABLE INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CHASE CARDIOVASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

DINAMAP PRO 1000 MONITOR, MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

FASTI INTRAOSSEOUS INFUSION SYSTEM

FDA Adverse Event
Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

UNKNOWN

FDA Adverse Event
Malfunction ·COOK, INC.·Product code DTK·August 21, 2014

UNK

FDA Adverse Event
Injury ·COOK, INC.·Product code DTK·August 20, 2014

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·August 20, 2014

SYNERGY

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 6, 2012

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 4, 2015

2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·April 23, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011

TRANSVENE

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·April 3, 2026

STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

FDA Enforcement
Class II ·Terminated·Diagnostica Stago, Inc.·November 14, 2012

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 3, 2015

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 11, 2014

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 12, 2017

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 11, 2021

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·December 5, 2017

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 4, 2025