9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUPREP
FDA 510(k)
FDA Class 2
·Cardiovascular
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885306220·dentaform® Band, tooth 36, size 6/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885306180·dentaform® Band, tooth 36, size 6/Roth 18
EMERGENCY-CLEAN UP(TM) ECP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CMI VACUUM DELIVERY SYSTEM #003C AND #004C
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 19, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 21, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 25, 2010
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019