FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

41 results for "Biotronik Sales, Inc."
25–41 of 41
Search insights Median review: 65d Cleared: 100% Top manufacturer: Biotronik Sales, Inc. Lead specialty: Cardiovascular
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared May 25, 1983
NEDS-01 & EPR-500
K830862 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Nov 01, 1982
KALOS-03 BIPOLAR
K822907 · DXY
Biotronik Sales, Inc.
Cardiovascular · 32d
Cleared May 07, 1982
PULSE GENERATOR
K821073 · DXY
Biotronik Sales, Inc.
Cardiovascular · 21d
Cleared Apr 09, 1982
IMPLANTABLE, MULTIPROGRAMMABLE
K820774 · DXY
Biotronik Sales, Inc.
Cardiovascular · 17d
Cleared Oct 13, 1981
KALOS-03
K812218 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · DTB
Biotronik Sales, Inc.
Cardiovascular · 164d
Cleared Mar 20, 1981
TYPE N ENDOCARDIAL LEAD
K810493 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE YR ENDOCARDIAL LEAD
K810492 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Mar 20, 1981
TYPE YC ENDOCARDIAL LEAD
K810491 · DTB
Biotronik Sales, Inc.
Cardiovascular · 24d
Cleared Apr 21, 1980
EPR-200 PROGRAMMER MODEL 010
K800376 · KRG
Biotronik Sales, Inc.
Cardiovascular · 60d
Cleared Apr 16, 1980
NOMOS-01 PULSE GENERATOR
K800375 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d