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
9121–9144 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 07, 2000
THE V-BAG
K001822 · DTN
Circulatory Technology, Inc.
Cardiovascular · 21d
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 224d
Cleared Jul 03, 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · DYB
Cordis Corp.
Cardiovascular · 84d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Omron Healthcare, Inc.
Cardiovascular · 14d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · DSB
Cardiodynamics International Corp.
Cardiovascular · 87d
Cleared Jun 30, 2000
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT...
K001664 · MHX
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
AGILENT COMPONENT MONITORING SYSTEM
K001722 · MHX
Agilent Technologies Deutschland GmbH
Cardiovascular · 24d
Cleared Jun 30, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
QUART ARTERIAL FILTER, MODEL HBF 140
K001787 · DTM
Jostra Medizintechnik AG
Cardiovascular · 17d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY...
K001180 · DTE
Pace Medical
Cardiovascular · 77d
Cleared Jun 27, 2000
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
K001305 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jun 23, 2000
GEMINI E
K993623 · DQD
Allen Medical Instruments Corp.
Cardiovascular · 241d
Cleared Jun 22, 2000
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · JOW
Britt Corp., Inc.
Cardiovascular · 451d
Cleared Jun 16, 2000
TEARAWAY INTRODUCER SHEATH
K000313 · DYB
Xentek Medical, Inc.
Cardiovascular · 136d
Cleared Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Jun 16, 2000
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · DQK
Tomtec Imaging Systems GmbH
Cardiovascular · 24d
Cleared Jun 14, 2000
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · DXJ
General Electric Medical Systems...
Cardiovascular · 69d
Cleared Jun 14, 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 183d
Cleared Jun 13, 2000
EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
K000237 · DXN
Cybercare, Inc.
Cardiovascular · 138d
Cleared Jun 13, 2000
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
K001762 · DXG
Pulsion Medical Systems, Inc.
Cardiovascular · 4d
Cleared Jun 09, 2000
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · DPS
Cambridge Heart, Inc.
Cardiovascular · 70d
Cleared Jun 09, 2000
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
K993316 · DXN
Ueda Avancer Corp.
Cardiovascular · 249d