Neomed, Inc.
Medical device manufacturer in Woodstock, GA.
17510(k) clearances
0PMA approvals
2recalls
Device types
- PNR Enteral Syringes With Enteral Specific… 4
- FPD Tube, Feeding 2
- FOS Catheter, Umbilical Artery 2
- FMF Syringe, Piston 2
- KNT Tubes, Gastrointestinal (And Accessories) 2
- HAM Apparatus, Electrosurgical 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- HIN Coagulator-Cutter, Endoscopic, Bipolar (And… 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- EZD Catheter, Straight 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…PNR · Traditional | 04/30/2019SE |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR · Traditional | 12/17/2015SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K100288 | Neomed Enteral Only Extension SetKNT · Traditional | 08/03/2010SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | 07/21/2008SE |
| K073596 | Neomed Single Lumen Umbilical CatheterFOS · Traditional | 02/22/2008SE |
| K072881 | NEOMED Enteral FEEDING TUBEFPD · Traditional | 01/09/2008SE |
| K072997 | Neomed Urinary CatheterEZD · Traditional | 12/19/2007SE |
| K885243 | NEOVO2R VentilatoryBTM · Traditional | 07/24/1989SE |
| K790043 | Tracor, Cannula, Bicepts BipolarHIN · Traditional | 02/08/1979SE |
| K781810 | Electrosurgical Unit 3001-3009GEI · Traditional | 12/20/1978SE |
| K780118 | Electrode, Dispersive, Disp. NeopadHAM · Traditional | 02/23/1978SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0526-2019 Class III | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect…The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is… | 10/24/2018Terminated |
| Z-0093-2019 Class II | NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr…Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors… | 06/04/2018Terminated |