11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
FDA 510(k)
FDA Class 2
·Dental
TAGA VELOCITY HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNL·October 1, 2014
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC EMERGENCY RESPONSE SYSTEM·Product code LDD·May 5, 2006
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026