10 results · 28ms · Sources: EU EUDAMED, 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