12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Calibra Abutment Resin Cement
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Sbo Hearing A/S·05714464055081·OTICON PLAY PX 1 MINIRITE R C079
Symmetry Mahorner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482060926·Symmetry® Retractor, Mahorner Thyroid, 7 Prong,...
OMNIBotics Knee System
FDA 510(k)
FDA Class 2
·Neurology
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
FDA 510(k)
FDA Class 2
·Neurology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962114681·MAHORNER THYROID RETRACTOR, 10 1/2", 7 PRONG
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·November 10, 2014
CT9000 ADV DOMESTIC BASIC SYS
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code DXT·August 16, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 22, 2013
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Recall
Terminated
·Vitrolife Inc·Product code KTO·December 22, 2014
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017