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
7537–7560 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 26, 2004
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
K041123 · DQO
Kerberos Proximal Solutions, Inc.
Cardiovascular · 118d
Cleared Aug 24, 2004
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · DSK
Schiller AG
Cardiovascular · 270d
Cleared Aug 24, 2004
PIESOMETER, MODEL MK-1
K041169 · DXN
Canamet Canadian Natl Medical...
Cardiovascular · 112d
Cleared Aug 24, 2004
FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01
K041400 · DXN
Fortifier International Co., Ltd.
Cardiovascular · 90d
Cleared Aug 24, 2004
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
K042138 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 15d
Cleared Aug 23, 2004
AIRGUARD VALVED INTRODUCER
K042036 · DYB
C.R. Bard, Inc.
Cardiovascular · 25d
Cleared Aug 18, 2004
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
K040490 · DXN
Welch Allyn, Inc.
Cardiovascular · 174d
Cleared Aug 18, 2004
HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
K040799 · DXN
Hommed, LLC
Cardiovascular · 142d
Cleared Aug 18, 2004
VENTURE WIRE CONTROL CATHETER
K040922 · DQY
Velocimed, Inc.
Cardiovascular · 132d
Cleared Aug 16, 2004
MICRO PRIME
K041650 · DWF
Innovx Medical, Inc.
Cardiovascular · 60d
Cleared Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d
Cleared Aug 16, 2004
2 CM PERIPHERAL CUTTING BALOON
K041993 · PNO
Boston Scientific Ivt
Cardiovascular · 24d
Cleared Aug 12, 2004
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
K042022 · DXH
Datrix, Inc. Dba of Jon Barron, Inc.
Cardiovascular · 15d
Cleared Aug 11, 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · DQY
Concentric Medical, Inc.
Cardiovascular · 141d
Cleared Aug 11, 2004
TERUMO CIRCUIT CONNECTORS
K041697 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 50d
Cleared Aug 10, 2004
HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
K040651 · DXN
Hommed, LLC
Cardiovascular · 152d
Cleared Aug 06, 2004
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
K032884 · NFA
Boston Scientific Epi
Cardiovascular · 325d
Cleared Aug 06, 2004
POWERHEART AED G3 PRO
K040637 · MKJ
Cardiac Science, Inc.
Cardiovascular · 149d
Cleared Aug 06, 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · DSB
Analogic Corp.
Cardiovascular · 70d
Cleared Aug 06, 2004
LYSUS INFUSION SYSTEM
K041629 · QEY
Ekos Corp.
Cardiovascular · 51d
Cleared Aug 06, 2004
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · DXQ
D. E. Hokanson, Inc.
Cardiovascular · 45d
Cleared Aug 06, 2004
FINISHING WIRE SUPPORTRAK
K041762 · DQX
Guidant Corporation
Cardiovascular · 37d
Cleared Aug 06, 2004
PERMANENT PACING LEAD, MODEL PY2
K041809 · DTB
Oscor, Inc.
Cardiovascular · 31d
Cleared Aug 06, 2004
DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
K042014 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 10d