11 results
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26ms
·
Sources: EU EUDAMED, US FDA
2-Way 100% Silicone Cleartract Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIAL HEAD FOR BROACH ESOP HA D.28 +10
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489330131·
MDIFICATION TO MEDIPRIME
FDA 510(k)
FDA Class 2
·Radiology
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·July 25, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
MX-PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 25, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·July 18, 2013
BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 31, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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