13 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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AMID STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ArgenZ HT+ 95x12
FDA UDI
ARGEN CORPORATION, THE·D818120268·Dental porcelain/ceramic restoration kit
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664008062·SOSOFT 30-40 KH RIB M SAND 1 EN FR ES
Base Plate Set Getinge A0, Getinge B0, Mizuho
FDA UDI
Noras MRI products GmbH·04251269205842·The NORAS OR Head Holder LUCY is used for intra...
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
ISAAC 1.5 T MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 12, 2024
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
MEGA 7.5FR. 40CC
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015