15 results · 20ms · Sources: EU EUDAMED, 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