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."
1–24 of 41
Search insights Median review: 65d Cleared: 100% Top manufacturer: Biotronik Sales, Inc. Lead specialty: Cardiovascular
Cleared Feb 18, 1988
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
K875199 · DTB
Biotronik Sales, Inc.
Cardiovascular · 62d
Cleared Mar 11, 1987
ERA-20
K853194 · DTE
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Jan 12, 1987
EDP-20 PACEMAKER
K860036 · DXY
Biotronik Sales, Inc.
Cardiovascular · 371d
Cleared Dec 10, 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
TRIOS-M VS-1 PULSE GENERATOR
K863878 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Sep 23, 1986
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480 · DTB
Biotronik Sales, Inc.
Cardiovascular · 14d
Cleared Aug 08, 1986
NEOS VS-1, PULSE GENERATOR
K860921 · DXY
Biotronik Sales, Inc.
Cardiovascular · 150d
Cleared Aug 04, 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · DXY
Biotronik Sales, Inc.
Cardiovascular · 146d
Cleared May 07, 1986
DJP UNIPOLAR
K853567 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DJ UNIPOLAR
K853566 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared Jan 15, 1986
DNR UNIPOLAR
K853568 · DTB
Biotronik Sales, Inc.
Cardiovascular · 142d
Cleared Sep 13, 1985
NEOS - M ABP
K853058 · DXY
Biotronik Sales, Inc.
Cardiovascular · 56d
Cleared Sep 12, 1985
TRIOS - M
K853057 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812 · DXY
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Feb 07, 1985
BIOTRONIK DY-UNIPOLAR
K841451 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
BIOTRONIK DNP UNIPOLAR
K841450 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Aug 06, 1984
NEOS LP
K841633 · DXY
Biotronik Sales, Inc.
Cardiovascular · 109d
Cleared Aug 03, 1984
LEPTOS
K841635 · DXY
Biotronik Sales, Inc.
Cardiovascular · 106d
Cleared Jun 25, 1984
PULSE GENERATOR KALOS-04
K841950 · DXY
Biotronik Sales, Inc.
Cardiovascular · 52d
Cleared Jun 25, 1984
NEOS M
K841636 · DXY
Biotronik Sales, Inc.
Cardiovascular · 67d