Company ยท US
Neomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2019. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | 4 |
| FPD | Tube, Feeding | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 |
| FMF | Syringe, Piston | 2 |
| FOS | Catheter, Umbilical Artery | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| EZD | Catheter, Straight | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HAM | Apparatus, Electrosurgical | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2019 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 Neomed, Inc. | PNR |
| Jun 17, 2016 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringe Neomed, Inc. | PNR |
| Dec 17, 2015 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps Neomed, Inc. | PNR |
| Apr 9, 2015 | K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector Neomed, Inc. | PNR |
| Sep 20, 2012 | K122373 | NEOMED ORAL/ENTERAL SYRINGE Neomed, Inc. | FMF |
| Apr 19, 2012 | K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES Neomed, Inc. | KNT |
| Aug 3, 2010 | K100288 | NEOMED ENTERAL ONLY EXTENSION SET Neomed, Inc. | KNT |
| Mar 10, 2010 | K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO Neomed, Inc. | FMF |
| Oct 1, 2008 | K082238 | NEOMED POLYURETHANE FEEDING TUBE Neomed, Inc. | FPD |
| Jul 21, 2008 | K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 Neomed, Inc. | FOS |
| Feb 22, 2008 | K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER Neomed, Inc. | FOS |
| Jan 9, 2008 | K072881 | NEOMED Enteral FEEDING TUBE Neomed, Inc. | FPD |
| Dec 19, 2007 | K072997 | NEOMED URINARY CATHETER Neomed, Inc. | EZD |
| Jul 24, 1989 | K885243 | NEOVO2R VENTILATORY Neomed, GB | BTM |
| Feb 8, 1979 | K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR Neomed Corp. | HIN |
| Dec 20, 1978 | K781810 | ELECTROSURGICAL UNIT 3001-3009 Neomed Corp. | GEI |
| Feb 23, 1978 | K780118 | ELECTRODE, DISPERSIVE, DISP. NEOPAD Neomed Corp. | HAM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2018 | Neomed Inc 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 Terminated |
KNT | K100288 |
| Oct 10, 2018 | Neomed Inc 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 Terminated |
FPD | K082238 |