8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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E-CUBE 5
FDA 510(k)
FDA Class 2
·Radiology
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
BMT GB KNEE STM 12X40
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·June 3, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 26, 2008
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026