Company ยท US
Promedic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2014. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| FOG | Hood, Oxygen, Infant | 1 |
| FRN | Pump, Infusion | 1 |
| GBM | Catheter, Urethral | 1 |
| KCY | Tourniquet, Pneumatic | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
| OSP | Uterine Electromyographic Monitor | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2014 | K131889 | EUM 100PRO Promedic, Inc. | OSP |
| Jun 29, 2012 | K112318 | CLEARPATH 24 Promedic, Inc. | OCX |
| Dec 19, 2007 | K072756 | NON-IV ADAPTER FOR INFANT NG TUBE Promedic, Inc. | KNT |
| Jul 11, 2006 | K060497 | BABYAIR Promedic, Inc. | CAF |
| Jun 21, 2006 | K060842 | REVJET TURBO Promedic, Inc. | CAF |
| Nov 9, 2005 | K052903 | PEDIATRIC FEEDING TUBE Promedic, Inc. | KNT |
| Jun 17, 2003 | K031409 | URINARY CATHETERS Promedic, Inc. | GBM |
| Mar 17, 2003 | K024190 | FENESTRATED INFUSION CATHETER Promedic, Inc. | FRN |
| Jan 28, 2003 | K023579 | GAS SAMPLING LINES Promedic, Inc. | CCK |
| Jul 16, 2002 | K020005 | INFANT FEEDING TUBES Promedic, Inc. | KNT |
| Jun 24, 1997 | K970102 | FILTER Promedic, Inc. | CAH |
| Jun 16, 1997 | K970991 | DATEX ENGSTOM MANUAL RESUSCITATOR Promedic, Inc. | BTM |
| Jul 15, 1996 | K962182 | BURLEW INFANT HOOD Promedic, Inc. | FOG |
| Nov 9, 1995 | K954201 | BUONAFEDE PNEUMATIC SLEEVE Promedic, Inc. | KCY |
| Jun 14, 1995 | K951988 | PRESSURIZER Promedic, Inc. | KZD |
| Jun 7, 1995 | K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK Promedic, Inc. | BSJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||