4 results
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6ms
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Sources: EU EUDAMED, US FDA
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 14, 2026
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 25, 2024
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 8, 2026
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·July 31, 2024