8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981743·anteriors; shade A3.5 light; mould UM10
Blood Transfer Accessory (BTA)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
FDA 510(k)
FDA Class 2
·Anesthesiology
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·February 8, 2011
UNKNOWN BONE MULCH SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HWC·August 5, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 27, 2016
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026