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
8953–8976 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 21, 2000
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
K001634 · DXH
Tz Medical, Inc.
Cardiovascular · 209d
Cleared Dec 21, 2000
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Dec 21, 2000
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K003248 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
PUMP TUBING WITH X-COATING
K003371 · DWF
Terumo Corp.
Cardiovascular · 52d
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB,...
K003598 · DSP
Datascope Corp.
Cardiovascular · 30d
Cleared Dec 21, 2000
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE,...
K003724 · DTR
Medtronic Vascular
Cardiovascular · 17d
Cleared Dec 21, 2000
MSD EMBOLECTOMY BASKET
K991093 · QEW
Metamorphic Surgical Devices, LLC
Cardiovascular · 630d
Cleared Dec 20, 2000
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
K003118 · DYG
Zcv ,Inc.
Cardiovascular · 76d
Cleared Dec 20, 2000
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 20, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
K003621 · MHX
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Dec 18, 2000
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM)...
K001927 · DSY
Thoratec Laboratories Corp.
Cardiovascular · 175d
Cleared Dec 18, 2000
EHC400 DESKTOP PATIENT STATION
K002984 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 84d
Cleared Dec 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K003622 · MWI
Agilent Technologies, Inc.
Cardiovascular · 24d
Cleared Dec 15, 2000
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
K003711 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 14d
Cleared Dec 14, 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228 · MKJ
Katecho, Inc.
Cardiovascular · 59d
Cleared Dec 13, 2000
NEXAN SYSTEM, MODEL NX-300
K003520 · MWJ
Nexan, Ltd.
Cardiovascular · 28d
Cleared Dec 07, 2000
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
K002481 · LDF
Zcv ,Inc.
Cardiovascular · 115d
Cleared Dec 07, 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452 · DRF
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2000
DARDIK CAROTID SHUNT
K001621 · MJN
Vascutech, Inc.
Cardiovascular · 194d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 135d
Cleared Dec 06, 2000
EECP THERAPY SYSTEM, MODEL TS3
K003469 · DRN
Vasomedical, Inc.
Cardiovascular · 28d