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Kentec Medical, Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
6
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2515-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2520-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2519-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2518-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2517-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2516-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-2514-2020Class IIAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use onlyJanuary 17, 2020
Z-3073-2017Class IIPOLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENFJune 23, 2017
Z-3074-2017Class IIPOLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) EJune 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETFebruary 17, 2012
K100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEApril 22, 2010
K050443ACCU-LEADSeptember 2, 2005
K970686ACCUTEMP-PROBEAugust 25, 1997
K960080ACCUTEMP PROBEMay 1, 1996
K853475GRAM-MA NEONATAL SCSeptember 5, 1985