11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788232130·Steerable Trial Caddy - 10x32
Legacy™2 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307101215·Ø3.2 x 13 Platform 3.0mmD
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
RDH-2000
FDA 510(k)
FDA Class 1
·Dental
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
ENDO STITCH POLYSORB* 3/0 7 VIO DLU SU
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY US SURGICAL·Product code GCJ·February 27, 2014
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 7, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 1, 2010
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025