11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DualX Lumbar Intervertebral Body Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015462·2.4mm x 34mm Cannulated Lag Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070867·Cannulated 2.4 x 34mm Lag Screw Sterile Qty 5
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HANCOCK
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 7, 2019
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
PUMP MMT-715RNAS PRDGM INS SK EN ML PR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 7, 2008
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013
OPTI-FREE REPLENISH
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABS, INC.·Product code LPN·July 27, 2011
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025