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

Filters: Cardiovascular ×
18,182 results
1465–1488 of 18,182
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 CT Feb 09, 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike...
K212211 · DQY
Vascular Solutions, LLC
Cardiovascular · 209d