10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STEAMLINE
FDA 510(k)
FDA Class 2
·General Hospital
Adante Knee Foot Support
FDA UDI
MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430116612·
ARGELITE 76SF+ DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
PLAKOF
FDA 510(k)
FDA Class 1
·Dental
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 4, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·July 28, 2020
DURASUL, ALPHA INSERT, HH/32
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·July 28, 2020
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024