Biotronik Sales, Inc.
41 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (K875199) | Biotronik Sales, Inc. | 1988-02-18 |
| ERA-20 (K853194) | Biotronik Sales, Inc. | 1987-03-11 |
| EDP-20 PACEMAKER (K860036) | Biotronik Sales, Inc. | 1987-01-12 |
| NEOS-M VS-1 PULSE GENERATOR (K863879) | Biotronik Sales, Inc. | 1986-12-10 |
| TRIOS-M VS-1 PULSE GENERATOR (K863878) | Biotronik Sales, Inc. | 1986-12-10 |
| BIOTRONIK PERMANENT PACEMAKER ELECTRODE (K863480) | Biotronik Sales, Inc. | 1986-09-23 |
| NEOS VS-1, PULSE GENERATOR (K860921) | Biotronik Sales, Inc. | 1986-08-08 |
| MIKROS, MIKROS VS-1, PULSE GENERATOR (K860922) | Biotronik Sales, Inc. | 1986-08-04 |
| DJP UNIPOLAR (K853567) | Biotronik Sales, Inc. | 1986-05-07 |
| DJ UNIPOLAR (K853566) | Biotronik Sales, Inc. | 1986-05-07 |
| DNR UNIPOLAR (K853568) | Biotronik Sales, Inc. | 1986-01-15 |
| NEOS - M ABP (K853058) | Biotronik Sales, Inc. | 1985-09-13 |
| TRIOS - M (K853057) | Biotronik Sales, Inc. | 1985-09-12 |
| NEOS-LP PULSE GENERATOR (K844842) | Biotronik Sales, Inc. | 1985-04-18 |
| NEOS-M PULSE GENERATOR (K844795) | Biotronik Sales, Inc. | 1985-04-18 |
| NEOS - PULSE GENERATOR (K844812) | Biotronik Sales, Inc. | 1985-04-18 |
| LEPTOS PULSE GENERATOR (K844794) | Biotronik Sales, Inc. | 1985-04-18 |
| KALOS-04 PULSE GENERATOR (K844841) | Biotronik Sales, Inc. | 1985-04-18 |
| BIOTRONIK DNP UNIPOLAR (K841450) | Biotronik Sales, Inc. | 1985-02-07 |
| BIOTRONIK DY-UNIPOLAR (K841451) | Biotronik Sales, Inc. | 1985-02-07 |
| NEOS LP (K841633) | Biotronik Sales, Inc. | 1984-08-06 |
| LEPTOS (K841635) | Biotronik Sales, Inc. | 1984-08-03 |
| PULSE GENERATOR KALOS-04 (K841950) | Biotronik Sales, Inc. | 1984-06-25 |
| NEOS M (K841636) | Biotronik Sales, Inc. | 1984-06-25 |
| BIOTRONIK DFH UNIPOLAR PE-60/4-DFH (K833106) | Biotronik Sales, Inc. | 1983-10-20 |
| BIOTRONIK N, BIPOLAR PEB-60/4-N (K833099) | Biotronik Sales, Inc. | 1983-10-20 |
| BIOTRONIK DN UNIPOLAR PE-60/4-DN & (K833098) | Biotronik Sales, Inc. | 1983-10-19 |
| BIOTRONIK D2K UNIPOLAR PE-60/4 (K833104) | Biotronik Sales, Inc. | 1983-10-19 |
| BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC (K833101) | Biotronik Sales, Inc. | 1983-10-19 |
| BIOTRONIK I-UNIPOLAR PE-60/2-13 (K833108) | Biotronik Sales, Inc. | 1983-10-19 |
| NEDS-01 & EPR-500 (K830862) | Biotronik Sales, Inc. | 1983-05-25 |
| KALOS-03 BIPOLAR (K822907) | Biotronik Sales, Inc. | 1982-11-01 |
| PULSE GENERATOR (K821073) | Biotronik Sales, Inc. | 1982-05-07 |
| IMPLANTABLE, MULTIPROGRAMMABLE (K820774) | Biotronik Sales, Inc. | 1982-04-09 |
| KALOS-03 (K812218) | Biotronik Sales, Inc. | 1981-10-13 |
| TYPE FH ENDOCARDIAL LEAD (K810494) | Biotronik Sales, Inc. | 1981-08-07 |
| TYPE YC ENDOCARDIAL LEAD (K810491) | Biotronik Sales, Inc. | 1981-03-20 |
| TYPE YR ENDOCARDIAL LEAD (K810492) | Biotronik Sales, Inc. | 1981-03-20 |
| TYPE N ENDOCARDIAL LEAD (K810493) | Biotronik Sales, Inc. | 1981-03-20 |
| EPR-200 PROGRAMMER MODEL 010 (K800376) | Biotronik Sales, Inc. | 1980-04-21 |
| NOMOS-01 PULSE GENERATOR (K800375) | Biotronik Sales, Inc. | 1980-04-16 |
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