23 results · 20ms · Sources: EU EUDAMED, US FDA

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EVITAXL WITH OPTION SMARTCARE

FDA 510(k)
FDA Class 2 ·Anesthesiology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58210512630·HOLDER, NEEDLE, GASTROENTEROLOGIC

MODIFICATION TO SPARC SLING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

FDA Adverse Event
Malfunction ·RICE CREEK MANUFACTURING·Product code DXY·April 10, 2013

HELIOS RESERVOIR, JAPAN

FDA Adverse Event
Malfunction ·PLAINFIELD-LOX-RX·Product code BYJ·May 22, 2008

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014