15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052023492·Sagittal Saw, Quick Release
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909130252·REVELATION DIAMOND 856-025SC - 5 PACK
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154185313·INSTRUMENT TRAY F. MAND. FRACTURE INSTR
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 15, 2021
MODIFICATION TO FLOUROLAB PLUS
FDA 510(k)
FDA Class 2
·Neurology
Laser hair growth helmet
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC B.V.·Product code MHY·June 28, 2022
SUMMIT RC+S
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 1, 2024
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·July 24, 2019
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 18, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
DAVINCI SI ENDOWRIST GRAPTOR
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·December 27, 2012
PERCEPT
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·December 11, 2024
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