8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDIFLEX INJECTION CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137350·
OPERAID DISPOS. IRRIGATING KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
HALIFAX SPINAL CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·Product code NBW·December 3, 2012
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
FDA Enforcement
Class I
·Ongoing·Abbott·October 22, 2025