9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984175·anteriors; shade A3.5; mould 98
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
#820/821 BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
FLOSEAL
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·February 10, 2011
CUP IMPACTOR BOLT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·August 6, 2014
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012