9 results · 19ms · Sources: EU EUDAMED, US FDA

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IS-ANTI-SM TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

artegral

FDA UDI
Merz Dental GmbH·D7091970220·anteriors; shade B3; mould ITM

OneQ-SL s-Clean Implant System

FDA 510(k)
FDA Class 2 ·Dental

OSTEOFIX BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·February 20, 2013

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·January 25, 2011

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LZG·July 31, 2014

Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise Listing number: D072377 Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.

FDA Recall
Terminated ·Teco Diagnostics·Product code KQO·October 14, 2011

Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.

FDA Recall
Terminated ·Teco Diagnostics·Product code KQO·October 14, 2011