Neomed, Inc.
Neomed, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2019, with 2 FDA device recalls on record.
Top product codes for Neomed, Inc.
FDA recalls by Neomed, Inc.
- Z-0526-2019 — NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
- Z-0093-2019 — NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement and is not intended for use beyond 30 days.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Neomed, Inc.
- K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
- K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
- K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector
- K122373 — NEOMED ORAL/ENTERAL SYRINGE
- K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
- K100288 — NEOMED ENTERAL ONLY EXTENSION SET
- K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
- K082238 — NEOMED POLYURETHANE FEEDING TUBE
- K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
- K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER
- K072881 — NEOMED Enteral FEEDING TUBE
- K072997 — NEOMED URINARY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.