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
2185–2208 of 18,110
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