30 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SONOLITH I-MOVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Bernafon AG·05711584005606·CT7 M, VC PS SF DB CANTEO 7
Flexitron
FDA UDI
Nucletron B.V.·08717213026544·Flexitron Transfer Tube for Metal Needles (3)
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
FDA 510(k)
FDA Class 2
·Orthopedic
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
FDA 510(k)
FDA Class 2
·General Hospital
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019
Ascendant
FDA UDI
Choice Spine, LP·10885862260895·
GELB MOUTHGUARD
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·April 10, 2019
ASTRON CLEAR SPRINT
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·January 14, 2020
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT INC.·Product code MQC·September 17, 2019
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·December 17, 2019
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT INC.·Product code MQC·September 16, 2019
ASTRON CLEAR SPLINT
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·July 22, 2020
ASTRON CLEAR SPLINT LOWER
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·January 30, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 8, 2024
ASTRON CLEAR SPLINTS
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code MQC·May 4, 2020
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
CLEARLINK CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021