13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOALA
FDA 510(k)
FDA Class 2
·Radiology
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463325·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260551·
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032597·ET40, KIT 312 NFM 90 PB L BE ENCHANT 40
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 6, 2015
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 7, 2008
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 4, 2011
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025