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
9529–9552 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 07, 1999
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
K981191 · DQY
Intratherapeutics, Inc.
Cardiovascular · 370d
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Mar 29, 1999
ADVANCED NIBP MODULE
K982641 · DXN
Johnson & Johnson Medical, Inc.
Cardiovascular · 243d
Cleared Mar 26, 1999
MICRINS MICRO ANASTOMOSIS CLAMP
K982278 · DXC
Micrins Surgical, Inc.
Cardiovascular · 270d
Cleared Mar 25, 1999
BCI MINI-TORR PLUS, MODEL 6004
K984618 · DXN
Bci Intl., Inc.
Cardiovascular · 86d
Cleared Mar 25, 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT...
K990639 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared Mar 24, 1999
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
K982136 · DTN
Schiff & Co.
Cardiovascular · 280d
Cleared Mar 24, 1999
IBC FLOPUMP, MODEL 6000
K983272 · KFM
International Biophysics Corp.
Cardiovascular · 188d
Cleared Mar 24, 1999
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
K984062 · DYB
Diag Corp.
Cardiovascular · 128d
Cleared Mar 23, 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT,...
K983346 · DQX
Guidant Corp.
Cardiovascular · 181d
Cleared Mar 23, 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · DWF
Heartport, Inc.
Cardiovascular · 14d
Cleared Mar 22, 1999
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
K990707 · DQY
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Mar 19, 1999
VASO PRESS SYSTEM
K974393 · JOW
Britt Corp., Inc.
Cardiovascular · 483d
Cleared Mar 19, 1999
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 25d
Cleared Mar 16, 1999
INTEGRITI PATIENT MONITOR
K980688 · MWI
Alliance Instruments
Cardiovascular · 386d
Cleared Mar 16, 1999
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
K984582 · MKJ
Bio-Detek, Inc.
Cardiovascular · 83d
Cleared Mar 15, 1999
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
K990805 · QEZ
Cordis Corp.
Cardiovascular · 4d
Cleared Mar 11, 1999
ZOLL M SERIES SPO2 OPTION
K982992 · MKJ
Zoll Medical Corp
Cardiovascular · 196d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Boston Scientific Corp
Cardiovascular · 182d
Cleared Mar 11, 1999
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
K983927 · DQT
Arterial Vascular Engineering, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · DXT
Medrad, Inc.
Cardiovascular · 91d
Cleared Mar 11, 1999
ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
K990573 · DXC
Estech, Inc.
Cardiovascular · 16d
Cleared Mar 09, 1999
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE...
K984271 · DTZ
Medtronic Vascular
Cardiovascular · 99d
Cleared Mar 09, 1999
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · DTP
C.R. Bard, Inc.
Cardiovascular · 19d