9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MotoBAND CP Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131342928·G200, MINIRITE 312 2.4G C090 HHM
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 17, 2023
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
FDA 510(k)
FDA Class 2
·Cardiovascular
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·October 8, 2008
SPINAL ANESTHESIA KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·July 13, 2011
M2A MAGNUM SYSTEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 27, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024