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
9745–9768 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 08, 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 204d
Cleared Jul 07, 1998
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
K972255 · LOS
Pulse Biomedical, Inc.
Cardiovascular · 385d
Cleared Jul 07, 1998
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
K972899 · DXQ
Cypress Medical Products, Ltd.
Cardiovascular · 335d
Cleared Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL)...
K980487 · KRH
Baxter Edwards
Cardiovascular · 148d
Cleared Jul 01, 1998
CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER
K971975 · DRF
Cardima, Inc.
Cardiovascular · 398d
Cleared Jul 01, 1998
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210,...
K980087 · DXC
Pressure Products, Inc.
Cardiovascular · 173d
Cleared Jun 30, 1998
MRI COMPATIBLE MONITOR AND ACCESSORIES
K980362 · DPS
Datex-Engstrom, Inc.
Cardiovascular · 152d
Cleared Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · LIT
Cook, Inc.
Cardiovascular · 28d
Cleared Jun 26, 1998
LIFE SUPPORT FOR TRAUMA AND TRANSPORT
K965117 · MKJ
Northrop Grumman Corp.
Cardiovascular · 553d
Cleared Jun 26, 1998
CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
K973298 · DQY
Cardima, Inc.
Cardiovascular · 297d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · DRT
Datascope Corp.
Cardiovascular · 232d
Cleared Jun 23, 1998
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC...
K981265 · LOS
Hewlett-Packard Co.
Cardiovascular · 77d
Cleared Jun 19, 1998
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
K973013 · LIT
Vas-Cath, Inc.
Cardiovascular · 310d
Cleared Jun 19, 1998
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
K980728 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 114d
Cleared Jun 18, 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · DXC
Boss Instruments, Ltd.
Cardiovascular · 167d
Cleared Jun 17, 1998
EASY RIDER MICRO CATHETER
K974473 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 203d
Cleared Jun 16, 1998
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
K980144 · DXH
Aerotel, Ltd.
Cardiovascular · 152d
Cleared Jun 15, 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · LOS
Hewlett-Packard Co.
Cardiovascular · 229d
Cleared Jun 12, 1998
COSGROVE CLAMP
K974769 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 172d
Cleared Jun 11, 1998
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
K964153 · DXN
Rossmax International , Ltd.
Cardiovascular · 603d
Cleared Jun 10, 1998
THE AMPLANTZ GOOSE NECK MICROSNARE
K970668 · DQY
Microvena Corp.
Cardiovascular · 471d
Cleared Jun 10, 1998
KAPLAN-SIMPSON INFUSASLEEVE II
K980957 · QEY
Localmed, Inc.
Cardiovascular · 86d
Cleared Jun 05, 1998
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 04, 1998
IAB-04840-U
K970689 · DSP
Arrow Intl., Inc.
Cardiovascular · 464d