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