8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rapid Reboot Compression Therapy System
FDA 510(k)
FDA Class 2
·Physical Medicine
BIO-SCREEN
FDA 510(k)
FDA Class 2
·Dental
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 26, 2024
SERVING TRAY, GRAY
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 21, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 28, 2011
INTELECT ADVANCED COMBO MONOCHROME
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IMG·September 25, 2008
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 17, 2014