8 results
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62ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·September 24, 2025
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024