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
9721–9744 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 07, 1998
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
K980504 · DYB
Schneider/Namic
Cardiovascular · 179d
Cleared Aug 07, 1998
MEDTRONIC ZUMA GUIDING CATHETER
K981198 · DQY
Medtronics Interventional Vascular
Cardiovascular · 127d
Cleared Aug 05, 1998
CT 200 ELECTROCARDIOGRAPH
K961798 · DPS
Macquarie Medical Systems
Cardiovascular · 818d
Cleared Aug 05, 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · JOW
Biomedical Horizons, Inc.
Cardiovascular · 440d
Cleared Aug 05, 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · DTN
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Aug 05, 1998
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
K981642 · DRF
Medtronic Cardiorhythm
Cardiovascular · 89d
Cleared Aug 04, 1998
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
K974648 · MOP
Sulzer Carbomedics, Inc.
Cardiovascular · 235d
Cleared Aug 04, 1998
FLO-THRU
K981624 · DXC
Bio-Vascular, Inc.
Cardiovascular · 89d
Cleared Jul 28, 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 85d
Cleared Jul 28, 1998
CT 100 ELECTROCARDIOGRAPH
K981951 · DPS
Macquarie Medical Systems
Cardiovascular · 90d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · DRX
3M Healthcare
Cardiovascular · 243d
Cleared Jul 25, 1998
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K982232 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 30d
Cleared Jul 24, 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · DXC
Cardio Medical Solutions, Inc.
Cardiovascular · 191d
Cleared Jul 22, 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 468d
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL...
K981083 · DTB
Biotronik, Inc.
Cardiovascular · 120d
Cleared Jul 17, 1998
Squirt Fluid Delivery System
K981417 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Jul 17, 1998
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
K981576 · MHX
Hewlett-Packard GmbH
Cardiovascular · 74d
Cleared Jul 17, 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
K981745 · DRS
Sunscope Intl., Inc.
Cardiovascular · 60d
Cleared Jul 15, 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · DWF
Heartport, Inc.
Cardiovascular · 208d
Cleared Jul 15, 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT...
K981381 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Jul 15, 1998
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
K981533 · DRG
American Telecare, Inc.
Cardiovascular · 77d
Cleared Jul 10, 1998
LAKE REGION MANUFACTURING GUIDEWIRES
K981326 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 88d
Cleared Jul 10, 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · DQO
Trinity Laboratories, Inc.
Cardiovascular · 80d
Cleared Jul 09, 1998
DEGANIA SILICONE IDENTI LOOPS
K981956 · DXC
Degania Silicone , Ltd.
Cardiovascular · 35d