3 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
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