8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
FDA 510(k)
FDA Class 2
·Microbiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982078·posteriors; shade C1; size S; upper jaw
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
MiniCollect K2E K2EDTA Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 8, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024