10 results
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19ms
·
Sources: EU EUDAMED, US FDA
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
FDA 510(k)
FDA Class 1
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756561266·MINOR TRAY
FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014
Hydrophilic Coating Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN DEPUY SZ. 14X09 S-ROM STEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWA·June 25, 2014
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 2, 2013
ACCU-CHEK SPIRIT
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020