15 results · 22ms · Sources: EU EUDAMED, US FDA

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WARMETTE

FDA 510(k)
FDA Class 1 ·Physical Medicine

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994237101·UNIVERSAL HANDLE 6971117

n/a

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994301871·TIP 7971117 DISTRACTOR 16MM

MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

Carefusion NeutraClear Needle-free connector (EL-NC1000)

FDA 510(k)
FDA Class 2 ·General Hospital

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 29, 2014

SYMBIQ SINGLE CHANNE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 1, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·January 26, 2011

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026