5 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;
FDA Enforcement
Class I
·Ongoing·Avanos Medical, Inc.·March 13, 2024
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22
FDA Enforcement
Class I
·Ongoing·Avanos Medical, Inc.·March 13, 2024
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·October 16, 2024
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020