Company ยท US
Burditt & Calkins-Siemens-Elema
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1984. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 |
| DSB | Plethysmograph, Impedance | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| FAE | Prosthesis, Penile | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| HGY | Pump, Breast, Non-Powered | 1 |
| KRB | Probe, Thermodilution | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 1984 | K833519 | PULSE GENERATOR MODEL 688 Burditt & Calkins-Siemens-Elema | DXY |
| Jan 26, 1984 | K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD Burditt & Calkins-Siemens-Elema | DSB |
| May 27, 1983 | K830344 | SIEMENS-ELMA PULSE GENERATOR #718 Burditt & Calkins-Siemens-Elema | DXY |
| Dec 30, 1982 | K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR Burditt & Calkins-Siemens-Elema | KRB |
| Dec 28, 1982 | K823591 | AMEDA HAND BREAST PUMP Burditt & Calkins-Siemens-Elema | HGY |
| Oct 4, 1982 | K822239 | COAXIAL BIPOLAR PACING ELECTRODE Burditt & Calkins-Siemens-Elema | DTB |
| Jul 26, 1982 | K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 Burditt & Calkins-Siemens-Elema | BTY |
| Jan 23, 1981 | K803111 | ERECTAID Burditt & Calkins-Siemens-Elema | FAE |
| Nov 19, 1980 | K802607 | TERPERATUR SENSING DEVICE Burditt & Calkins-Siemens-Elema | FLL |
| Oct 22, 1976 | K760787 | LIBERATOR/STROLLER Burditt & Calkins-Siemens-Elema | BYJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||