6 results
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25ms
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Sources: EU EUDAMED, US FDA
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·February 19, 2014
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
FDA Enforcement
Class II
·Terminated·Custom Assemblies Inc·August 30, 2017
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012