Biotronik Sales, Inc. - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
41 devices
Cleared
Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
Cardiovascular
38d
Cleared
Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
Cardiovascular
37d
Cleared
Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
Cardiovascular
37d
Cleared
Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
Cardiovascular
37d
Cleared
Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
Cardiovascular
37d
Cleared
May 25, 1983
NEDS-01 & EPR-500
Cardiovascular
68d
Cleared
Nov 01, 1982
KALOS-03 BIPOLAR
Cardiovascular
32d
Cleared
May 07, 1982
PULSE GENERATOR
Cardiovascular
21d
Cleared
Apr 09, 1982
IMPLANTABLE, MULTIPROGRAMMABLE
Cardiovascular
17d
Cleared
Oct 13, 1981
KALOS-03
Cardiovascular
68d
Cleared
Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
Cardiovascular
164d
Cleared
Mar 20, 1981
TYPE YC ENDOCARDIAL LEAD
Cardiovascular
24d
Cleared
Mar 20, 1981
TYPE YR ENDOCARDIAL LEAD
Cardiovascular
24d
Cleared
Mar 20, 1981
TYPE N ENDOCARDIAL LEAD
Cardiovascular
24d
Cleared
Apr 21, 1980
EPR-200 PROGRAMMER MODEL 010
Cardiovascular
60d
Cleared
Apr 16, 1980
NOMOS-01 PULSE GENERATOR
Cardiovascular
55d