27 results
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7ms
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Sources: EU EUDAMED, US FDA
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 15, 2026
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
FDA Enforcement
Class II
·Ongoing·CAREFUSION·September 22, 2021
MicroScan Neg MIC 3J REF C54814
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 15, 2026
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
FDA Enforcement
Class II
·Ongoing·Medical Information Technology, Inc.·September 24, 2025
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
FDA Enforcement
Class II
·Ongoing·Remel Inc·March 16, 2022
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 1, 2026
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·December 28, 2022