13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446909040·SPECIAL, RSP 2.4mm CANNULATED GLENOID REAMER, M...
NA
FDA UDI
Synthes GmbH·10886982143181·2.0MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIOFASTIN RC THREADED SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·October 16, 2018
RESOLUTE INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·October 16, 2018
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 26, 2013
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 21, 2008
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025