11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128939·Femoral Augment, Notched Posterior, Size 3+, 10mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690188278·NOTCHED POSTERIOR AUGMENT TRIAL REVISION FEMUR ...
Helio A7 Manual Wheelchair, Move Manual Wheelchair
FDA 510(k)
FDA Class 1
·Physical Medicine
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
FDA 510(k)
FDA Class 2
·Orthopedic
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 11, 2014
5FR DUAL-LUMEN UVC CATH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FOS·November 21, 2008
54 CM BIPOLAR LEAD
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTB·July 18, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021