9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
FDA 510(k)
FDA Class 1
·Microbiology
Modulus
FDA UDI
Nuvasive, Inc.·00887517024206·Modulus ALIF Trial, 10x42x32mm 30° XL
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NFC-700 non-mydriatic auto fundus camera
FDA 510(k)
FDA Class 2
·Ophthalmic
PENUMBRA SYSTEM 3MAX SEPARATOR
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 18, 2014
VIPER 2 X-TAB 6X45MM TI
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NKB·December 20, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012