8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OpenLoc-L Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MobileLink Acetabular Cup System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575192373·Orthopaedic implant impactor - MobileLink Aceta...
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
FDA 510(k)
FDA Class 2
·Ophthalmic
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 28, 2011
VET STD TPLO JIG
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·June 21, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 17, 2014
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025