118 results
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26ms
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Sources: EU EUDAMED, US FDA
IRRIGATION/SUCTION PROBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
CERVICAL COLLAR
FDA 510(k)
FDA Class 1
·Physical Medicine
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
ASR ACETABULAR IMP 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 9, 2010
REACH ACCESS DAILY FLOSSER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·January 22, 2013
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 9, 2014
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 28, 2015
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 29, 2025
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·May 16, 2024
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·August 21, 2013
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 21, 2021
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 6, 2025
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·September 15, 2023
GUIDE WIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 25, 2025
RADIFOCUS GUIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·December 5, 2023
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 3, 2018
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 23, 2026
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 11, 2026