10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
FDA 510(k)
FDA Class 2
·Cardiovascular
GAS CYLINDER RESTRAINER KIT US
FDA UDI
Maquet Critical Care AB·07325710005705·
LARGE AO COUPLING ASNIS III HALL FITTING
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 25, 2012
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSFER-TRAX (TM) SPLINT TRACTION
FDA 510(k)
FDA Class 1
·Orthopedic
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 19, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 25, 2010
TRIDENT 10DEG X3 INSERT 32MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·December 17, 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
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