Neomed Inc
Neomed Inc appears in FDA public data with 2 recalls, 17 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0526-2019, Class III) was initiated on October 24, 2018. Its most recent 510(k) clearance was granted on April 30, 2019.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Known Names
neomed, neomed co
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0526-2019 | Class III | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral O | October 24, 2018 |
| Z-0093-2019 | Class II | NeoMed 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-Number | Device | Date |
|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with | April 30, 2019 |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip | June 17, 2016 |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | December 17, 2015 |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | April 9, 2015 |
| K122373 | NEOMED ORAL/ENTERAL SYRINGE | September 20, 2012 |
| K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES | April 19, 2012 |
| K100288 | NEOMED ENTERAL ONLY EXTENSION SET | August 3, 2010 |
| K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO | March 10, 2010 |
| K082238 | NEOMED POLYURETHANE FEEDING TUBE | October 1, 2008 |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | July 21, 2008 |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | February 22, 2008 |
| K072881 | NEOMED Enteral FEEDING TUBE | January 9, 2008 |
| K072997 | NEOMED URINARY CATHETER | December 19, 2007 |
| K885243 | NEOVO2R VENTILATORY | July 24, 1989 |
| K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR | February 8, 1979 |
| K781810 | ELECTROSURGICAL UNIT 3001-3009 | December 20, 1978 |
| K780118 | ELECTRODE, DISPERSIVE, DISP. NEOPAD | February 23, 1978 |