723 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
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
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 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
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
FDA Enforcement
Class II
·Terminated·Nanosphere, Inc.·October 1, 2014
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
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