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
8905–8928 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 07, 2001
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
K000776 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 334d
Cleared Feb 07, 2001
ANCURE LLIAC BALLOON CATHETER
K003495 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 86d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · DTL
Terumo Cardiovascular Systems Corp.
Cardiovascular · 78d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · MKJ
Medical Devices, Inc.
Cardiovascular · 194d
Cleared Feb 01, 2001
M2376A DEVICELINK SYSTEM
K010048 · MWI
Agilent Technologies, Inc.
Cardiovascular · 27d
Cleared Feb 01, 2001
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
K010099 · LDF
Zcv ,Inc.
Cardiovascular · 21d
Cleared Feb 01, 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER,...
K990284 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 734d
Cleared Jan 31, 2001
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
K002445 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 175d
Cleared Jan 31, 2001
VERTEX SYSTEM
K002822 · DPS
Medical Positioning, Inc.
Cardiovascular · 142d
Cleared Jan 30, 2001
APPALEAD GW+03XXXXXXR SERIES
K003394 · DQX
Nipro Medical Corp.
Cardiovascular · 90d
Cleared Jan 29, 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · DXN
Welch Allyn, Inc.
Cardiovascular · 257d
Cleared Jan 29, 2001
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
K002273 · DWF
Stoeckert Instrumente
Cardiovascular · 187d
Cleared Jan 29, 2001
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K002791 · DXN
Unix Electronic Co. , Ltd.
Cardiovascular · 144d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467 · DXZ
Chase Medical, Inc.
Cardiovascular · 82d
Cleared Jan 25, 2001
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
K001961 · DWF
Stoeckert Instrumente
Cardiovascular · 212d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cook, Inc.
Cardiovascular · 210d
Cleared Jan 25, 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K002007 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 206d
Cleared Jan 25, 2001
CARDIO MONITOR CENTER VISION
K003392 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 86d
Cleared Jan 25, 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · DSI
Quinton, Inc.
Cardiovascular · 66d
Cleared Jan 25, 2001
DR180+OXY
K004007 · DSH
North East Monitoring, Inc.
Cardiovascular · 30d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · DRT
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jan 19, 2001
ACROTHERM
K003368 · DWJ
Aquarius Medical Corp.
Cardiovascular · 81d
Cleared Jan 19, 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND...
K003964 · DTK
Cordis Corp.
Cardiovascular · 28d
Cleared Jan 18, 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · DTD
Biotronik, Inc.
Cardiovascular · 72d