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
5137–5160 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 18, 2011
MITRA-LIFT
K103812 · KRH
Sciencity Co., Ltd.
Cardiovascular · 140d
Cleared May 18, 2011
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
K103377 · DQX
Brivant, Ltd.
Cardiovascular · 182d
Cleared May 17, 2011
MAC 600 RESTING ECG ANALYSIS SYSTEM
K103765 · DPS
Ge Medical Systems Information...
Cardiovascular · 145d
Cleared May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 210d
Cleared May 13, 2011
ONESTEP PEDIATRIC MFE'S
K110978 · MKJ
ZOLL Medical Corporation
Cardiovascular · 36d
Cleared May 13, 2011
ELECTRONIC SPHYGMOMANOMETER
K110775 · DXN
Contec Medical Systems Co.,Ltd
Cardiovascular · 53d
Cleared May 13, 2011
ELECTRONIC SPHYGMOMANOMETER
K110774 · DXN
Contec Medical System Co., Ltd.
Cardiovascular · 53d
Cleared May 13, 2011
TERUMO SUPPORT CATHETER
K110540 · DQY
Terumo Medical Corp.
Cardiovascular · 77d
Cleared May 13, 2011
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
K103473 · DXJ
ZOLL Medical Corporation
Cardiovascular · 170d
Cleared May 12, 2011
ACTIVECARE SFT
K110159 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 113d
Cleared May 10, 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · DYB
St Jude Medical
Cardiovascular · 83d
Cleared May 10, 2011
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL...
K102725 · DQY
Bridge Medical, Inc.
Cardiovascular · 231d
Cleared May 05, 2011
ENSITE VELOCITY SYSTEM
K110549 · DQK
St Jude Medical
Cardiovascular · 69d
Cleared May 05, 2011
VENODYNE V810
K110358 · JOW
Microtek Medical, Inc.
Cardiovascular · 87d
Cleared May 04, 2011
SENSILASE PAD-IQ
K110438 · DPW
Vasamed, Inc.
Cardiovascular · 78d
Cleared May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE...
K103764 · DSI
Medtronic, Inc.
Cardiovascular · 132d
Cleared May 02, 2011
WEBSTER DUO-DECAPOLAR CATHETER
K101991 · DRF
Biosense Webster, Inc.
Cardiovascular · 292d
Cleared Apr 29, 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY...
K110909 · NTE
Abbott Laboratories
Cardiovascular · 29d
Cleared Apr 29, 2011
PTS-X SIZING BALLOON CATHETER
K110903 · MJN
NuMED, Inc.
Cardiovascular · 29d
Cleared Apr 29, 2011
MAC 5500 HD, MAC 3500
K110266 · DPS
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared Apr 27, 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
K110845 · KFM
Abiomed, Inc.
Cardiovascular · 30d
Cleared Apr 20, 2011
JETSTREAM NAVITUS SYSTEM
K110626 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 47d
Cleared Apr 20, 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
K110461 · DQY
Biotronik, Inc.
Cardiovascular · 62d
Cleared Apr 19, 2011
SPACELABS SMART DISCLOSURE SYSTEM
K110779 · DQK
Spacelabs Healthcare
Cardiovascular · 29d