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
2761–2784 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 22, 2017
NOWCARDIO SYSTEM
K162956 · QYX
Contex International Technologies...
Cardiovascular · 333d
Cleared Sep 19, 2017
ECOM™ Cardiac Output Monitoring System
K172196 · DSB
Ecom Medical, Inc.
Cardiovascular · 60d
Cleared Sep 15, 2017
M-CATH Microcatheter
K171176 · DQY
Acrostak (Schweiz) AG
Cardiovascular · 147d
Cleared Sep 15, 2017
Glidewire GT
K170417 · DQX
Terumo Corporation
Cardiovascular · 217d
Cleared Sep 14, 2017
Masimo Rad-97 and Accessories
K170168 · MWI
Masimo Corporation
Cardiovascular · 238d
Cleared Sep 11, 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 60d
Cleared Sep 09, 2017
All-in-One Health Monitor, PC-303
K170047 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 247d
Cleared Sep 08, 2017
014 Hydrophilic Coated PTA Balloon Dilatation Catheter
K171251 · LIT
Creagh Medical
Cardiovascular · 133d
Cleared Sep 08, 2017
Medline Hemo-Force DVT Compression Sleeve
K170415 · JOW
Medline Industries, Inc.
Cardiovascular · 210d
Cleared Sep 08, 2017
QMAPP Amplifier
K170032 · MWI
Fysicon BV
Cardiovascular · 247d
Cleared Sep 08, 2017
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava...
K163699 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 253d
Cleared Sep 07, 2017
XableCath Support Catheter
K170041 · DQY
Xablecath, Inc.
Cardiovascular · 245d
Cleared Sep 06, 2017
Steerable Guide Catheter
K172394 · DRA
Abbott Vascular
Cardiovascular · 29d
Cleared Sep 01, 2017
RhythmView Workstation
K171583 · DQK
Abbott Electrophysiology
Cardiovascular · 93d
Cleared Sep 01, 2017
Prizma
K170181 · DXH
G-Medical Innovations , Ltd.
Cardiovascular · 225d
Cleared Aug 31, 2017
Pirouette High Pressure (HP)
K172033 · LIT
Arravasc, Ltd.
Cardiovascular · 57d
Cleared Aug 30, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K170467 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 195d
Cleared Aug 29, 2017
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
K170958 · DXC
Tricol Biomedical, Inc.
Cardiovascular · 151d
Cleared Aug 28, 2017
Captus Vascular Retrieval System
K170987 · MMX
Avantec Vascular Corporation
Cardiovascular · 147d
Cleared Aug 25, 2017
Hi-Torque Command 18 Guide Wire
K172073 · DQX
Abbott Vascular
Cardiovascular · 46d
Cleared Aug 24, 2017
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy...
K172386 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 16d
Cleared Aug 24, 2017
Liver Access and Biopsy Sets
K171853 · DYB
Cook Incorporated
Cardiovascular · 64d
Cleared Aug 23, 2017
Physiotrace
K171244 · DRX
Nimbleheart, Inc.
Cardiovascular · 117d
Cleared Aug 23, 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 152d