8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993046·anteriors; shade A2; mould IL
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
FDA 510(k)
FDA Class 2
·Neurology
Straumann® Retentive System Novaloc TiN Abutments
FDA 510(k)
FDA Class 2
·Dental
SMARTSTITCH SUTURING DEVICE HANDLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code KOG·March 1, 2013
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 16, 2011
MYOCARDIAL LEAD
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016