12 results
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32ms
·
Sources: EU EUDAMED, US FDA
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
ONPG TEST REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 19, 2014
UNKNOWN DEPUY SZ3 8MM CVD INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·October 22, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 26, 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 Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
SPIRAL COMBINATION HAMMER 500 GRAMS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZY·November 13, 2024
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