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."
25–48 of 85
Search insights Median review: 77d Cleared: 93% Top manufacturer: Biotronik, Inc. Lead specialty: Cardiovascular
Cleared Oct 08, 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · DQY
Biotronik, Inc.
Cardiovascular · 73d
Cleared Mar 19, 2015
BioMonitor
K143503 · MXD
Biotronik, Inc.
Cardiovascular · 99d
Cleared Dec 05, 2014
Passeo-35 PTA Catheter
K142379 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Jun 06, 2014
BIOMONITOR
K132960 · MXD
Biotronik, Inc.
Cardiovascular · 259d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978 · DQY
Biotronik, Inc.
Cardiovascular · 56d
Cleared Apr 23, 2013
PASSEO-35
K130161 · LIT
Biotronik, Inc.
Cardiovascular · 90d
Cleared Jan 11, 2013
SELECTRA 7F CATHETERS
K123324 · DQY
Biotronik, Inc.
Cardiovascular · 77d
Cleared Sep 26, 2011
SELECTRA SLITTER TOOL
K112482 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2011
SELECTRA ACCESSORY KIT
K111839 · DQY
Biotronik, Inc.
Cardiovascular · 89d
Cleared May 23, 2011
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
K111154 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Apr 20, 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
K110461 · DQY
Biotronik, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2010
SCOUTPRO ACS
K101776 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Jul 21, 2010
SCOUTPRO HEMOSTATIC VALVE
K101282 · DQY
Biotronik, Inc.
Cardiovascular · 76d
Cleared Nov 20, 2009
SCOUTPRO 7F LONG CATHETERS
K093303 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Apr 01, 2009
PK-141 PATIENT CABLE
K083674 · DTC
Biotronik, Inc.
Cardiovascular · 111d
Cleared Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
K082935 · DQX
Biotronik, Inc.
Cardiovascular · 64d
Cleared Nov 03, 2008
PASSEO-35 PTA CATHETER
K082933 · DQY
Biotronik, Inc.
Cardiovascular · 33d
Cleared May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Mar 25, 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
K072329 · DQY
Biotronik, Inc.
Cardiovascular · 218d
Cleared Dec 20, 2007
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230 · DTA
Biotronik, Inc.
Cardiovascular · 35d
Cleared Dec 12, 2007
PASSEO 18
K072765 · LIT
Biotronik, Inc.
Cardiovascular · 75d
Cleared Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
K071665 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 10, 2006
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212 · DTB
Biotronik, Inc.
Cardiovascular · 70d