Promedic, Inc.
Medical device manufacturer in Bonita Springs, FL.
16510(k) clearances
0PMA approvals
0recalls
Device types
- KNT Tubes, Gastrointestinal (And Accessories) 3
- CAF Nebulizer (Direct Patient Interface) 2
- BSJ Mask, Gas, Anesthetic 1
- KZD Infusor, Pressure, For I.V. Bags 1
- KCY Tourniquet, Pneumatic 1
- FOG Hood, Oxygen, Infant 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- CAH Filter, Bacterial, Breathing-Circuit 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
- FRN Pump, Infusion 1
- GBM Catheter, Urethral 1
- OCX Endoscopic Irrigation/Suction System 1
- OSP Uterine Electromyographic Monitor 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K131889 | Eum 100PROOSP · Traditional | 04/23/2014SE |
| K112318 | Clearpath 24OCX · Traditional | 06/29/2012SE |
| K072756 | Non-Iv Adapter for Infant NG TubeKNT · Traditional | 12/19/2007SESK |
| K060497 | BabyairCAF · Traditional | 07/11/2006SE |
| K060842 | Revjet TurboCAF · Traditional | 06/21/2006SE |
| K052903 | Pediatric Feeding TubeKNT · Traditional | 11/09/2005SE |
| K031409 | Urinary CathetersGBM · Traditional | 06/17/2003SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | 03/17/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
| K020005 | Infant Feeding TubesKNT · Traditional | 07/16/2002SE |
| K970102 | FilterCAH · Traditional | 06/24/1997SE |
| K970991 | Datex Engstom Manual ResuscitatorBTM · Traditional | 06/16/1997SESK |
| K962182 | Burlew Infant HoodFOG · Traditional | 07/15/1996SE |
| K954201 | Buonafede Pneumatic SleeveKCY · Traditional | 11/09/1995SE |
| K951988 | PressurizerKZD · Traditional | 06/14/1995SE |
| K951043 | Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional | 06/07/1995SE |