358 results
·
7ms
·
Sources: EU EUDAMED, US FDA
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·June 25, 2025
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
FDA Enforcement
Class II
·Ongoing·Ossur H / F·October 9, 2024
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
CLARITY II Laser System; Model No. 1110200210.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·March 18, 2026
Genesis Push-In Suture Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Biocomposite Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Dual Thread Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Max Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026