FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
8377–8400 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 28, 2002
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K011461 · LDD
Access Cardiosystems, Inc.
Cardiovascular · 379d
Cleared May 28, 2002
PADPRO, MODEL 2502
K020743 · MKJ
Padpro, LLC
Cardiovascular · 83d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661 · MSX
General Electric Medical Systems...
Cardiovascular · 84d
Cleared May 24, 2002
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K020701 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 81d
Cleared May 23, 2002
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING...
K020587 · KRB
Pulsion Medical Systems AG
Cardiovascular · 90d
Cleared May 22, 2002
N2000 BASE STATION
K020584 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 90d
Cleared May 22, 2002
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
K021225 · DXN
Rossmax International , Ltd.
Cardiovascular · 34d
Cleared May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 26d
Cleared May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
K021435 · MWI
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared May 22, 2002
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
K021447 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 16d
Cleared May 22, 2002
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT...
K021591 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 7d
Cleared May 21, 2002
MEDAMICUS AXIA RSN
K020563 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared May 17, 2002
SMARTWIRE/SMARTMAP PRESSURE SYSTEM
K021219 · DQX
Jomed, Inc.
Cardiovascular · 30d
Cleared May 17, 2002
Z3 GUIDE CATHETER
K021256 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Boston Scientific Corp
Cardiovascular · 28d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK...
K021228 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · MHX
Philips Medical Systems
Cardiovascular · 12d
Cleared May 14, 2002
REPROCESSED COMPRESSION LIMB SLEEVES
K012658 · JOW
Surgical Instruments Service and...
Cardiovascular · 274d
Cleared May 08, 2002
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
K012712 · MLO
Norav Medical , Ltd.
Cardiovascular · 267d
Cleared May 08, 2002
COMPRESSIBLE LIMB SLEEVE
K012979 · JOW
Medical Device Services, Inc.
Cardiovascular · 245d
Cleared May 08, 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376 · DPW
Hemedex Incorporated
Cardiovascular · 209d
Cleared May 08, 2002
PADPRO MODEL #2516
K020203 · MKJ
Padpro, LLC
Cardiovascular · 106d
Cleared May 08, 2002
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · DXE
Atrium Medical Corp.
Cardiovascular · 70d
Cleared May 08, 2002
Q-STRESS ECHO BED
K021171 · DPS
Medical Positioning, Inc.
Cardiovascular · 26d