Biotronik, GmbH & Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051April 6, 2000
K923406BIOSCOPESeptember 22, 1993
K923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERAugust 19, 1993
K922742HPM 40 HEART PACEMAKER MONITORMarch 18, 1993
K914109PIKOS 01 & PIKOS E 01February 26, 1992
K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIPAugust 28, 1991
K911142LEAD TERMINAL PIN CAPS, VARIOUS MODELSAugust 9, 1991
K910608PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIPJuly 30, 1991
K905087TRIOS 02May 7, 1991
K903928LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UPOctober 16, 1990
K903929LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UPOctober 16, 1990
K903927LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UPOctober 16, 1990
K903081NEOS (TM) 02 B PULSE GENERATORSeptember 14, 1990
K902889A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.August 23, 1990
K896824BIOTRONIK'S PS-ENDOCARDIAL LEADSAugust 8, 1990
K901709DNP 60-B UNIPOLAR ENDOCARDIAL LEADMay 22, 1990
K901332PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGEMay 9, 1990
K894494LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEADOctober 17, 1989