8 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erchonia PL Touch
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM
MEDELA SWING BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
PULSE GEN MODEL UNK
FDA Adverse Event
Death
·CYBERONICS INC.·Product code LYJ·June 28, 2011
PFC SIGMA MOD TIB TRAY CEM SZ5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 5, 2008
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023