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Biotronik Sales, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORFebruary 18, 1988
K853194ERA-20March 11, 1987
K860036EDP-20 PACEMAKERJanuary 12, 1987
K863878TRIOS-M VS-1 PULSE GENERATORDecember 10, 1986
K863879NEOS-M VS-1 PULSE GENERATORDecember 10, 1986
K863480BIOTRONIK PERMANENT PACEMAKER ELECTRODESeptember 23, 1986
K860921NEOS VS-1, PULSE GENERATORAugust 8, 1986
K860922MIKROS, MIKROS VS-1, PULSE GENERATORAugust 4, 1986
K853566DJ UNIPOLARMay 7, 1986
K853567DJP UNIPOLARMay 7, 1986
K853568DNR UNIPOLARJanuary 15, 1986
K853058NEOS - M ABPSeptember 13, 1985
K853057TRIOS - MSeptember 12, 1985
K844841KALOS-04 PULSE GENERATORApril 18, 1985
K844794LEPTOS PULSE GENERATORApril 18, 1985
K844795NEOS-M PULSE GENERATORApril 18, 1985
K844812NEOS - PULSE GENERATORApril 18, 1985
K844842NEOS-LP PULSE GENERATORApril 18, 1985
K841450BIOTRONIK DNP UNIPOLARFebruary 7, 1985
K841451BIOTRONIK DY-UNIPOLARFebruary 7, 1985