8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY ACROMED MOSS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984378·anteriors; shade B4; mould R 75
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UREA NITROGEN TEST (BUN) ITEM #65408
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 2014
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 10, 2011
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024