19 results · 24ms · Sources: EU EUDAMED, US FDA

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Axis Spine Technologies ALIF

FDA 510(k)
FDA Class 2 ·Orthopedic

Impervious Gown

FDA UDI
MEDIVATORS INC.·00677964067839·Impervious Gown

DIAGNOSOFT HARP MODEL 2.06

FDA 510(k)
FDA Class 2 ·Radiology

SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE

FDA 510(k)
FDA Class 2 ·Orthopedic

POWER STICK M4

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code GEY·January 14, 2026

POWER STICK M4

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code GEY·December 29, 2025

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

POWER STICK M5/3

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code GEY·June 12, 2023

RESECTOR TOOTHED Ø 2MM

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code HWE·June 23, 2022

VERTEBRIS

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code HWE·July 6, 2023

VERTEBRIS

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code HWE·July 6, 2023

NA

FDA Adverse Event
Malfunction ·RICHARD WOLF GMBH·Product code HWE·August 29, 2022

CONNECTION CABLE WL 3M

FDA Adverse Event
Injury ·RICHARD WOLF GMBH·Product code HRX·November 29, 2023

CONNECTION CABLE WL 3M

FDA Adverse Event
Injury ·RICHARD WOLF GMBH·Product code GEY·October 4, 2024

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014