Panels › Anesthesiology › Product code NDC · Class 2
Calculator, Drug Dose
Regulation 868.1890
5510(k)s in 12 months (56 all time)
3recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in NDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Monarch Medical Technologies | 6 | 2 |
| Roche Diabetes Care, Inc. | 1 | 6 |
| Medtronic Minimed | 2 | 4 |
| Voluntis Sa. | 5 | 1 |
| Companion Medical, Inc. | 4 | 1 |
| Glytec, LLC | 4 | 0 |
| Glooko, Inc. | 2 | 0 |
| Roche Diagnostics Corp. | 2 | 0 |
| Sanofi | 2 | 0 |
| Welldoc, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2000 | K000418 | PDT DOSECALCULATOR, MODEL 80000 Retinalabs.Com | NDC |
| Dec 20, 1988 | K884016 | DC-1 I.V. DOSAGE COMPUTER Phase Medical, Inc. | NDC |
| Oct 18, 1988 | K882001 | DIACARE MONITORING SYSTEM Healthware Corp. | NDC |
| Dec 10, 1986 | K864121 | PHARMACOKINETICS SOFTWARE SYSTEM (PPS) Pharmatrol, Inc. | NDC |
| Mar 27, 1986 | K854249 | COMPUTER ASSISTED DIABETIC INTRUCTION Applied Biomedical Computations, Inc. | NDC |
| Jan 8, 1986 | K851573 | ABBOTT PHARAMACOKINETICS SYSTEMS Abbott Laboratories | NDC |
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