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."
49–72 of 85
Search insights Median review: 77d Cleared: 93% Top manufacturer: Biotronik, Inc. Lead specialty: Cardiovascular
Cleared Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
K060807 · DQY
Biotronik, Inc.
Cardiovascular · 31d
Cleared Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
K060655 · DQY
Biotronik, Inc.
Cardiovascular · 22d
Cleared Mar 02, 2005
GALEO FOCUS GUIDE WIRE
K042373 · DQX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Oct 20, 2004
ERA 3000 PACING SYSTEM ANALYZER
K042708 · DTE
Biotronik, Inc.
Cardiovascular · 20d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · DTA
Biotronik, Inc.
Cardiovascular · 21d
Cleared Nov 19, 2003
SCOUT PRO
K033320 · DQY
Biotronik, Inc.
Cardiovascular · 35d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · DTB
Biotronik, Inc.
Cardiovascular · 211d
Cleared Jan 27, 2003
ERA 3000
K022360 · DTA
Biotronik, Inc.
Cardiovascular · 192d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · DTB
Biotronik, Inc.
Cardiovascular · 27d
Cleared Oct 18, 2002
AROX 45-JBP
K023099 · DTB
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · DQX
Biotronik, Inc.
Cardiovascular · 82d
Cleared May 01, 2002
AROX 53-BP
K021217 · DTB
Biotronik, Inc.
Cardiovascular · 14d
Cleared Apr 09, 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · DTB
Biotronik, Inc.
Cardiovascular · 434d
Cleared Jan 18, 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · DTD
Biotronik, Inc.
Cardiovascular · 72d
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · DTB
Biotronik, Inc.
Cardiovascular · 98d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · DQX
Biotronik, Inc.
Cardiovascular · 56d
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · DTB
Biotronik, Inc.
Cardiovascular · 29d
Cleared Apr 13, 2000
EX 45-BP, MODEL 330 132
K994240 · DTB
Biotronik, Inc.
Cardiovascular · 119d
Cleared Dec 17, 1999
YP 45/15-BP
K993139 · DTB
Biotronik, Inc.
Cardiovascular · 88d
Cleared Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · DXY
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · DTB
Biotronik, Inc.
Cardiovascular · 85d
Cleared Jun 03, 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · DTB
Biotronik, Inc.
Cardiovascular · 107d
Cleared Jan 08, 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL...
K982272 · DQX
Biotronik, Inc.
Cardiovascular · 193d