11 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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`THE INSEMINATOR' (PROPOSED)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984306·anteriors; shade B2; mould 94
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471193444·K-WIRE - SINGLE TROCAR 3.0mm DIA x 150mm
BICAP ABLATING FORCEPS BAF-7
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·February 10, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 6, 2014
23GA ILLUMINATED DIRECTIONAL LASER PROBE
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQB·March 19, 2020
25GA ILLUMINATED DIRECTIONAL LASER PROBE
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQB·March 19, 2020
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