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