10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medtronic Model 53401 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OPACITY + BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013
80 LB. TORQUE SCREW ASSEMBLY
FDA Adverse Event
Malfunction
·INTEGRA, CINCINNATI·Product code HBL·May 5, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 17, 2014
SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code NEW·October 24, 2024
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020