9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G-EYE System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
LINK Instruments - Saw and drill guides
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359561·Orthopaedic implant aiming/guiding block, reusa...
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-EUGENOL TEMPORARY CEMENT
FDA 510(k)
FDA Class 1
·Dental
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO.·Product code IRT·August 15, 2011
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025