Panels › General, Plastic Surgery › Product code BTA · Class 2
Pump, Portable, Aspiration (Manual Or Powered)
Regulation 878.4780
7510(k)s in 12 months (160 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in BTA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 10 | 0 |
| Ohio Medical Corporation | 2 | 5 |
| S S C O R Inc | 0 | 6 |
| Aeros Instruments, Inc. | 5 | 0 |
| Egnell, Inc. | 5 | 0 |
| Precision Medical, Inc. | 3 | 2 |
| Thomas Industries | 5 | 0 |
| Sscor | 4 | 0 |
| Advanced Cytometrix, Inc. | 3 | 0 |
| Haemonetics Corp. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 1983 | K831085 | SYNEVAC VACUUM SOURCE UNIT Synemed, Inc. | BTA |
| May 18, 1983 | K831007 | CONNECTING TUBES Medovations, Inc. | BTA |
| Aug 6, 1982 | K821321 | SNYDER DEBRIBEMENT SYSTEM LDP-1 Snyder Laboratories, Inc. | BTA |
| May 21, 1982 | K820739 | KEYMED KEY VAC SUCTION PUMP Keymed, Inc. | BTA |
| Mar 2, 1982 | K820338 | IMPACT, MODELS 306/307 Impact Instrumentation, Inc. | BTA |
| Dec 31, 1981 | K813312 | UNIVERSAL SUCTION PUMP TYPE EUS Egnell, Inc. | BTA |
| Dec 9, 1981 | K813095 | GASTRIC JUICES SUCTION PUMP Egnell, Inc. | BTA |
| Oct 20, 1981 | K812020 | EGNELL COMPACT, TYPE EHV Egnell, Inc. | BTA |
| Mar 13, 1981 | K810490 | GOMCO SUCTION PUMP CABINET CHANGE Allied Healthcare Products, Inc. | BTA |
| Sep 7, 1979 | K791349 | SYSTEC 280 INTEGRATED SUCTION SYSTEM Stryker Corp. | BTA |
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