9 results · 20ms · Sources: EU EUDAMED, 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