15 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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DUTAU-NOVATECH®
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578938·CoRoent Ant TLIF Ti, 14x12x32mm 4°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152741·24F x 2.3cm MiniSPC Low Profile Suprapubic Cath...
Fingertip Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 2, 2024
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 23, 2024
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 10, 2024
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 21, 2024
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 6, 2024
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 11, 2014
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·November 20, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026