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
7561–7584 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 05, 2004
INFUSIONCATH
K041517 · QEY
Id, LLC
Cardiovascular · 59d
Cleared Aug 03, 2004
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
K033685 · KRH
Medical Cv, Inc.
Cardiovascular · 253d
Cleared Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 56d
Cleared Jul 28, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 271d
Cleared Jul 28, 2004
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772 · MHX
Datex-Ohmeda
Cardiovascular · 27d
Cleared Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · OBJ
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2004
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790 · MHX
Datex-Ohmeda
Cardiovascular · 21d
Cleared Jul 23, 2004
TRIO MONITOR
K041907 · MWI
Datascope Corp.
Cardiovascular · 8d
Cleared Jul 23, 2004
M2376A DEVICELINK SYSTEM
K041942 · MWI
Phillips Medical Systems
Cardiovascular · 4d
Cleared Jul 22, 2004
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
K041151 · DQY
Kerberos Proximal Solutions, Inc.
Cardiovascular · 80d
Cleared Jul 22, 2004
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
K041453 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 51d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716 · DXZ
Boston Scientific Corp
Cardiovascular · 28d
Cleared Jul 21, 2004
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
K041411 · DXN
Microlife Corp.
Cardiovascular · 55d
Cleared Jul 21, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS...
K041741 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 23d
Cleared Jul 20, 2004
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054
K041376 · MWI
Analogic Corp.
Cardiovascular · 57d
Cleared Jul 19, 2004
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION...
K040010 · QEW
Genesis Medical Interventional, Inc.
Cardiovascular · 196d
Cleared Jul 19, 2004
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
K041338 · MWS
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 19, 2004
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K041816 · DRG
Rtx Healthcare A/S
Cardiovascular · 13d
Cleared Jul 16, 2004
QUINTON Q-TE
K041607 · MHX
Quinton Cardiology, Inc.
Cardiovascular · 31d
Cleared Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Jul 15, 2004
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · JOW
Tyco Healthcare
Cardiovascular · 126d
Cleared Jul 15, 2004
NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
K041789 · DXN
Meditec Co., Ltd.
Cardiovascular · 13d
Cleared Jul 12, 2004
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
K033858 · LDF
European Custom Manufacturing BV
Cardiovascular · 214d
Cleared Jul 12, 2004
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
K041574 · DTD
Guidant Corporation
Cardiovascular · 28d