Company ยท US
Biodynamics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2006. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSB | Plethysmograph, Impedance | 3 |
| CAC | Apparatus, Autotransfusion | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 2 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JPI | Device, Hematocrit Measuring | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
| KPE | Container, I.V. | 1 |
| LIF | Dialyzer Reprocessing System | 1 |
| MNW | Analyzer, Body Composition | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 2006 | K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER Biodynamics Corp. | MNW |
| Nov 17, 1988 | K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER Biodynamics Corp. | DSB |
| Sep 9, 1988 | K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR Biodynamics Corp. | CAC |
| Jul 28, 1988 | K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER Biodynamics Corp. | DSB |
| Mar 16, 1988 | K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER Biodynamics Corp. | DSB |
| Mar 9, 1988 | K873807 | AUTOTRANSFUSION APPARATUS Biodynamics Corp. | CAC |
| Oct 23, 1987 | K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR Biodynamics Corp. | LIF |
| Feb 27, 1987 | K870052 | INFUMIX MIXING CONTAINER Biodynamics Corp. | KPE |
| Sep 30, 1982 | K822716 | UNIVERSAL CENTRIFUGE Biodynamics Corp. | JPI |
| Sep 30, 1982 | K822715 | PLATELET CENTRIFUGE Biodynamics Corp. | JQC |
| Sep 2, 1982 | K822422 | BASIC CENTRIFUGE Biodynamics Corp. | JQC |
| Jul 2, 1982 | K821741 | URICACID Biodynamics Corp. | KNK |
| May 14, 1982 | K821091 | ACCUCHEK BG. Biodynamics Corp. | CGA |
| Mar 11, 1982 | K820465 | CHEMSTRIP UG Biodynamics Corp. | CGA |
| Oct 2, 1981 | K812677 | UNITEST-POTASSIUM Biodynamics Corp. | CEJ |
| Jul 27, 1981 | K811189 | CHEMSTRIP L Biodynamics Corp. | GHD |
| Jul 23, 1981 | K811680 | ACCUDEX Biodynamics Corp. | JJQ |
| Feb 4, 1981 | K810075 | AUTOCLIX Biodynamics Corp. | FMK |
| Feb 2, 1981 | K810105 | BCA 1000 Biodynamics Corp. | JJQ |
| Dec 18, 1980 | K802842 | SINGLE VIAL LIPASE TEST KIT Biodynamics Corp. | CHI |
| Nov 12, 1980 | K802521 | CK-MB(IMMUNOLOGICAL) Biodynamics Corp. | JHS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||