10 results
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26ms
·
Sources: EU EUDAMED, US FDA
MUL-T-BLANKET
FDA 510(k)
FDA Class 2
·Physical Medicine
Skipjack
FDA UDI
Seaspine Orthopedics Corporation·10889981140038·10mm x 28mm x 12mm, 6-20 Deg
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
PLM A+ SPANISH DEVICE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·March 17, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·November 14, 2012
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·September 13, 2010
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014