12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sphero Attachments
FDA UDI
Preat Corporation·00842092123324·Sphero Block Abutment Ankylos 4.5 x 2mm (1.8mm ...
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006809·VITROS Chemistry Products RF Reagent
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031681·Rhoton® Needle Holder, Bayonet, Curved
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133543·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580172900001·SURE-SNAP 2. MOLAR UPR RGT SZ 29
MODIFICATION TO GFX NERVE ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
FOCUS
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 27, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022