26 results
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14ms
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Sources: EU EUDAMED, US FDA
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
FDA Enforcement
Class II
·Ongoing·Koven Technology, Inc.·April 1, 2026
MIM software; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·MIM Software Inc·March 12, 2025
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
FDA Enforcement
Class II
·Ongoing·LimFlow, Inc.·February 4, 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
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
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
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 20 Fr PULL Model/Catalog Number: 7180-20
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
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 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 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 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 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 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