12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cronus HP PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000868093·PLATE 6190037 ANTERIOR CERVICAL 37.5MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235855·PLATE 6190037 ANTERIOR CERVICAL 37.5MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189671·AK3 AP 4 IN 1 CUTTING GUIDE SIZE 6+
Rod Reduction Forceps
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045821·
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
FDA 510(k)
FDA Class 2
·Orthopedic
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
FDA 510(k)
FDA Class 2
·Cardiovascular
PALAXPRESS, CLEAR, 1000G POWDER
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013
ENDOMAXX ESOPHAGEAL STENT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code ESW·September 18, 2014
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 29, 2011
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 9, 2015