8 results
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23ms
·
Sources: EU EUDAMED, US FDA
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
FDA 510(k)
FDA Class 1
·Radiology
YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HCH·February 19, 2014
AbClose - Port Site Closure Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRIMARY SOLUTION SALVENT BASED COAT- MET
FDA 510(k)LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·June 25, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 2, 2013
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 4, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024