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

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NEXTGEN ALTIUS OCT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SCREW, UNKNOWN TYPE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

SCREW, UNKNOWN TYPE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLASMALITE PULSED LIGHT SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 21, 2013

SHOPKO

FDA Adverse Event
Injury ·ASO LLC·Product code KGX·September 18, 2014

HI-TORQUE WHISPER MS GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·June 13, 2011

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025