14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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StealthFix Intraosseous Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578785·CoRoent Ant TLIF Ti, 13x12x32mm 4°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102404·ALIO SCIMITAR PRECHOPPER
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOENCODER
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 2, 2011
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
8010042-2008-00134
FDA Adverse Event
Malfunction
·Product code CBK·August 19, 2008
NEEDLE 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GAA·April 15, 2024
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025