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Neomed Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Known Names

neomed, neomed co

Recent Recalls

NumberClassProductDate
Z-0526-2019Class IIINEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral OOctober 24, 2018
Z-0093-2019Class IINeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, June 4, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes withApril 30, 2019
K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip June 17, 2016
K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsDecember 17, 2015
K143344NeoMed NeoConnect Enteral Syringes with ENFit ConnectorApril 9, 2015
K122373NEOMED ORAL/ENTERAL SYRINGESeptember 20, 2012
K120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESApril 19, 2012
K100288NEOMED ENTERAL ONLY EXTENSION SETAugust 3, 2010
K092908NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EOMarch 10, 2010
K082238NEOMED POLYURETHANE FEEDING TUBEOctober 1, 2008
K081515NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0July 21, 2008
K073596NEOMED SINGLE LUMEN UMBILICAL CATHETERFebruary 22, 2008
K072881NEOMED Enteral FEEDING TUBEJanuary 9, 2008
K072997NEOMED URINARY CATHETERDecember 19, 2007
K885243NEOVO2R VENTILATORYJuly 24, 1989
K790043TRACOR, CANNULA, BICEPTS BIPOLARFebruary 8, 1979
K781810ELECTROSURGICAL UNIT 3001-3009December 20, 1978
K780118ELECTRODE, DISPERSIVE, DISP. NEOPADFebruary 23, 1978