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
2257–2280 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 13, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · DXN
Health & Life Co., Ltd.
Cardiovascular · 136d
Cleared Jun 13, 2019
Fiberoptix IAB
K190117 · DSP
Arrow International, Inc.
Cardiovascular · 140d
Cleared Jun 12, 2019
Life Sensor Cardiac Monitor
K191331 · DRG
Braveheart Wireless, Inc.
Cardiovascular · 27d
Cleared Jun 11, 2019
Scoreflex PTA Scoring Balloon Catheter
K182713 · PNO
Orbusneich Medical Trading, Inc.
Cardiovascular · 257d
Cleared Jun 07, 2019
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
K190916 · DRG
Vitalconnect, Inc.
Cardiovascular · 59d
Cleared Jun 07, 2019
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
K183649 · DRF
Baylis Medical Company, Inc.
Cardiovascular · 163d
Cleared Jun 07, 2019
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic...
K183632 · DRF
Baylis Medical Company, Inc.
Cardiovascular · 163d
Cleared Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183535 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jun 03, 2019
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK...
K182503 · LDD
Physio-Control, Inc.
Cardiovascular · 264d
Cleared May 30, 2019
FlexSeal Introducer Sheath with Hydrophilic Coating
K190628 · DYB
Freudenberg Medical Mis, Inc.
Cardiovascular · 79d
Cleared May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...
K190623 · OCL
Medtronic
Cardiovascular · 80d
Cleared May 30, 2019
GaltTWS
K182660 · DRB
Galt Medical Corp.
Cardiovascular · 247d
Cleared May 29, 2019
MitraClip G4 Steerable Guide Catheter
K190167 · DRA
Abbott
Cardiovascular · 118d
Cleared May 28, 2019
Nihon Kohden SVM-7200 Series Vital Signs Monitor
K190468 · MWI
Nihon Kohden Corporation
Cardiovascular · 91d
Cleared May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 102d
Cleared May 23, 2019
Upstream GoBack Crossing Catheter
K182937 · DQY
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 213d
Cleared May 23, 2019
IMPEDE-FX Embolization Plug
K182390 · KRD
Shape Memory Medical
Cardiovascular · 261d
Cleared May 22, 2019
RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter...
K190902 · DXQ
Wenzhou Renhua Instruments Co., Ltd.
Cardiovascular · 44d
Cleared May 21, 2019
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen...
K183646 · QAQ
Edwards Lifeciences, LLC
Cardiovascular · 146d
Cleared May 20, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
K190134 · DXN
Health & Life Co., Ltd.
Cardiovascular · 112d
Cleared May 20, 2019
VersaCross Transseptal Sheath
K183655 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 144d
Cleared May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
K191029 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 17, 2019
CardioGard Emboli Protection Cannula
K182302 · DWF
Cardiogard Medical, Ltd.
Cardiovascular · 266d
Cleared May 16, 2019
Carnation Ambulatory Monitor
K191000 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d