35 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEONE SPA
FDA UDI
LEONE SPA·08033707018148·CALIBRA 1ST MOLAR BANDS n.LL 27
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696417·Dynamic Dental Implant Ø6mm L16mm
POWDERED (WHITE) VINYL PATIENT EXAMINATION
FDA 510(k)
FDA Class 1
·General Hospital
SURGICAL FACE MASK; SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILAIRO NASAL PILLOWS MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream Console
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx DownStream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx DownStream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx DownStream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx DownStream System
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream Cartridge