Biotronik, GmbH & Co. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biotronik, GmbH & Co. - FDA 510(k) Cleared Devices
18
Total
17
Cleared
0
Denied
Biotronik, GmbH & Co. has 17 FDA 510(k) cleared cardiovascular devices. Based in Lake Oswego, US.
Historical record: 17 cleared submissions from 1989 to 2000.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biotronik, GmbH & Co.
18 devices
Cleared
Apr 06, 2000
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
Cardiovascular
28d
Cleared
Sep 22, 1993
BIOSCOPE
Cardiovascular
439d
Cleared
Aug 19, 1993
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
Cardiovascular
422d
Cleared
Mar 18, 1993
HPM 40 HEART PACEMAKER MONITOR
Cardiovascular
283d
Cleared
Feb 26, 1992
PIKOS 01 & PIKOS E 01
Cardiovascular
166d
Cleared
Aug 28, 1991
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
Cardiovascular
197d
Cleared
Aug 09, 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
Cardiovascular
148d
Cleared
Jul 30, 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
Cardiovascular
168d
Cleared
May 07, 1991
TRIOS 02
Cardiovascular
175d
Cleared
Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
Cardiovascular
57d
Cleared
Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
Cardiovascular
57d
Cleared
Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
Cardiovascular
57d
Cleared
Sep 14, 1990
NEOS (TM) 02 B PULSE GENERATOR
Cardiovascular
64d
Cleared
Aug 23, 1990
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
Cardiovascular
52d
Cleared
Aug 08, 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
Cardiovascular
247d
Cleared
May 22, 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
Cardiovascular
39d
Cleared
May 09, 1990
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
Cardiovascular
48d
Cleared
Oct 17, 1989
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
Cardiovascular
90d