Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

85 results for "Biotronik, Inc."
73–85 of 85
Search insights Median review: 77d Cleared: 93% Top manufacturer: Biotronik, Inc. Lead specialty: Cardiovascular
Cleared Sep 10, 1998
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120...
K980869 · DTB
Biotronik, Inc.
Cardiovascular · 188d
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL...
K981083 · DTB
Biotronik, Inc.
Cardiovascular · 120d
Not Cleared Mar 04, 1998
TIR/TIJ AND POLYROX
K972500 · DTB
Biotronik, Inc.
Cardiovascular · 244d
Not Cleared Jan 27, 1998
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
K965106 · DTB
Biotronik, Inc.
Cardiovascular · 403d
Not Cleared Aug 14, 1997
BK-N SEALING CAP
K971930 · DTD
Biotronik, Inc.
Cardiovascular · 79d
Not Cleared Aug 14, 1997
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · DTD
Biotronik, Inc.
Cardiovascular · 192d
Cleared Jul 10, 1997
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K964190 · DTE
Biotronik, Inc.
Cardiovascular · 262d
Cleared Apr 29, 1997
BK-A
K970204 · DTD
Biotronik, Inc.
Cardiovascular · 98d
Not Cleared Mar 10, 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION...
K964604 · DTB
Biotronik, Inc.
Cardiovascular · 112d
Not Cleared Sep 27, 1996
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER...
K953044 · DTB
Biotronik, Inc.
Cardiovascular · 455d
Cleared Mar 04, 1996
PIKOS LP 01, PIKOS LP E01
K945627 · DXY
Biotronik, Inc.
Cardiovascular · 474d
Cleared Sep 29, 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · DXY
Biotronik, Inc.
Cardiovascular · 134d
Cleared Aug 30, 1994
PIKOS E 01-B
K941937 · DXY
Biotronik, Inc.
Cardiovascular · 131d