388 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
XERF EFFECTOR 60. Electrosurgical unit.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·October 22, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Portable X-ray system
FDA Enforcement
Class II
·Ongoing·DIGIMED CO., LTD·July 30, 2025
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
FDA Enforcement
Class II
·Ongoing·IDS LTD·January 15, 2025
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·May 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step P in vitro diagnostic test REF: 8194
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
FDA Enforcement
Class II
·Ongoing·The Metrix Company·November 20, 2024