10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Switzerland
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Saphetor SA
Manufacturer
🇨🇭 Switzerland
MEDIREL SA
Manufacturer
🇨🇭 Switzerland·2 Importers
SnugFit ASA Extension
FDA 510(k)
FDA Class 2
·Orthopedic
Dent4You AG
Manufacturer
🇨🇭 Switzerland·3 Importers
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·October 9, 2019
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·March 4, 2015
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
FDA Enforcement
Class II
·Ongoing·Zimmer GmbH·September 18, 2024
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
FDA Enforcement
Class II
·Ongoing·Zimmer GmbH·September 18, 2024
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·March 8, 2023
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 27, 2025