Company ยท US
Medical Industries America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2005. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 7 |
| BTI | Compressor, Air, Portable | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 |
| KIC | Cushion, Flotation | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYG | Mask, Oxygen | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 |
| ITI | Wheelchair, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2005 | K050990 | REMREST HEATED HUMIDIFIER Medical Industries America, Inc. | BTT |
| May 28, 2004 | K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 Medical Industries America, Inc. | CAF |
| May 4, 2001 | K002763 | REMREST Medical Industries America, Inc. | BZD |
| Apr 20, 2001 | K011053 | OPTIMA Medical Industries America, Inc. | ITI |
| Jan 10, 1997 | K964078 | 3050 SPORT-NEB Medical Industries America, Inc. | CAF |
| Mar 21, 1995 | K943990 | 3000 AEROSOL TWO Medical Industries America, Inc. | CAF |
| Mar 10, 1995 | K942444 | 3002 AEROMAX Medical Industries America, Inc. | CAF |
| Mar 2, 1995 | K941961 | 605 VACU-MAX Medical Industries America, Inc. | BTA |
| Feb 24, 1995 | K942208 | 4003 AEROLITE Medical Industries America, Inc. | CAF |
| Feb 21, 1995 | K940630 | 503 MAXI COMPRESSOR Medical Industries America, Inc. | BTI |
| Apr 23, 1991 | K905593 | SLEEPAP Medical Industries America, Inc. | BZD |
| Mar 27, 1991 | K903499 | MINI-MICRON CIRCUIT Medical Industries America, Inc. | CAF |
| Feb 12, 1991 | K904045 | #504 MINI COMPRESSOR Medical Industries America, Inc. | BTI |
| Feb 12, 1991 | K902184 | MAXI ASPIRATOR Medical Industries America, Inc. | BTI |
| Apr 26, 1990 | K900686 | MAXI COMPRESSORS Medical Industries America, Inc. | BTI |
| Apr 16, 1990 | K894215 | EVOLUTION ULTRASONIC Medical Industries America, Inc. | CCQ |
| Oct 19, 1989 | K894642 | SLEEPAP MASK Medical Industries America, Inc. | BYG |
| Nov 14, 1986 | K864109 | C' AIRECUSH SEAT CUSHION Medical Industries America, Inc., AU | KIC |
| Nov 14, 1986 | K864108 | PUSH CUSH Medical Industries America, Inc., AU | KIC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2004 | Medical Industries America Inc RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA. Terminated |
BZD | K002763 |
| Nov 5, 2004 | Medical Industries America Inc Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the fo Terminated |
CAF | K032849 |