136 results
·
52ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·November 15, 2017
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·May 31, 2023
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·May 31, 2023
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·May 31, 2023
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021
Nasal Pack, part number PSS2186
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Orbitofacial Pack, part number AMS5850(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Laparoscopy Pack (1184), part number AMS6562
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Chest Breast Drape, part number AMS5853
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Vein Tray, part number AMS6312
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Pack (1185), part number AMS6560
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Facial Pack , part number AMS6501
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Setup Tray, part number AMS6414
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Hip Pack (1347), part number AMS6564
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Head/Neck Pack, part number AMS6121
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Stem Pack, part number AMS5166
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017