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
1393–1416 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 18, 2022
Cardio Flow Peripheral Guide Wire
K213834 · DQX
Cardio Flow Inc.,
Cardiovascular · 99d
Cleared Mar 18, 2022
OPTRELL Mapping Catheter with TRUEref Technology
K211438 · MTD
Biosense Webster, Inc.
Cardiovascular · 312d
Cleared Mar 15, 2022
VoqX Electronic Stethoscope
K212709 · DQD
Sanolla , Ltd.
Cardiovascular · 201d
Cleared Mar 14, 2022
OPN NC PTCA Dilatation Catheter
K212393 · LOX
Sis Medical AG
Cardiovascular · 224d
Cleared Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · PNE
Innovative Health, LLC
Cardiovascular · 241d
Cleared Mar 09, 2022
Amplatzer Steerable Delivery Sheath
K220340 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Mar 04, 2022
Patient Information Center iX
K211900 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 256d
Cleared Mar 01, 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
K220109 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 47d
Cleared Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
K213189 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 153d
Cleared Mar 01, 2022
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
K212057 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 243d
Cleared Mar 01, 2022
GoBack Crossing Catheter
K211802 · PDU
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 264d
Cleared Feb 25, 2022
FEops HEARTguide
K214066 · QQI
Feops NV
Cardiovascular · 60d
Cleared Feb 24, 2022
Cleaner Plus Thrombectomy System
K211798 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 259d
Cleared Feb 18, 2022
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
K213503 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 109d
Cleared Feb 17, 2022
Lunderquist Extra Stiff Wire Guide
K220137 · DQX
William Cook Europe Aps
Cardiovascular · 30d
Cleared Feb 17, 2022
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab...
K213972 · DQK
Ge Healthcare Information...
Cardiovascular · 59d
Cleared Feb 17, 2022
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
K212977 · DQO
Cordis Corporation
Cardiovascular · 153d
Cleared Feb 17, 2022
Xtractor device
K211679 · DRE
Xcardia Innovation , Ltd.
Cardiovascular · 261d
Cleared Feb 14, 2022
Fogarty Occlusion Catheter
K211610 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared Feb 14, 2022
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
K203793 · DRF
Synaptic Medical Corporation
Cardiovascular · 413d
Cleared Feb 11, 2022
Zyter RPM
K212622 · MSX
Zyter, Inc.
Cardiovascular · 177d
Cleared Feb 10, 2022
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed...
K211327 · DRF
CathRx, Ltd.
Cardiovascular · 283d
Cleared Feb 09, 2022
Veinoflow SCD (Model: LBTK-M-I 5006)
K213313 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 128d
Cleared Feb 09, 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike...
K212211 · DQY
Vascular Solutions, LLC
Cardiovascular · 209d