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

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ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ARTIS Q ZEEGO

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970584·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970591·

CD HORIZON VOYAGER SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LIAISON XL ANALYZER MODEL 10050

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code EQN·June 9, 2011

ILIAC SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

POLARIS SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

FDA Enforcement
Class II ·Terminated·Deerfield Imaging·March 23, 2016

CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020

POLARIS CURVED ROD, UNKNOWN

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019

POLARIS TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

POLARIS CURVED ROD, UNKNOWN

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019

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