21 results · 21ms · Sources: EU EUDAMED, US FDA

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COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040114544·HP Intraoral Tips Yellow Small

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704292947·

NA

FDA UDI
KEY SURGICAL, INC.·10849771049323·K-Wires, Double diamond, .045-inch (1.1mm) diam...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484498·K-Wire w. double end lanzet point _x000D_...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189923·TAPERED TIBIAL TRAY DRILL

K-Wire w. double end lanzet point 1.1mm/102mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM712020·K-Wire w. double end lanzet point 1.1mm/...

DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

WALPEO TABLH

FDA 510(k)
FDA Class 1 ·Physical Medicine

IBALANCE TKA TIBIAL TRAY SIZE 5

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code JWH·September 5, 2019

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 1, 2013

CONCERTO CRT-D DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NIK·January 26, 2011

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 8, 2014

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

Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

FDA Enforcement
Class II ·Terminated·Arthrex, Inc.·March 30, 2016