FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10729–10752 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488 · DRX
Graphic Controls Corp.
Cardiovascular · 147d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
K950489 · DRX
Graphic Controls Corp.
Cardiovascular · 147d
Cleared Jun 30, 1995
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · DTR
Gish Biomedical, Inc.
Cardiovascular · 305d
Cleared Jun 29, 1995
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD
K951087 · DTB
Pacesetter, Inc.
Cardiovascular · 112d
Cleared Jun 29, 1995
MODEL PV2000 VASCULAR MICROLABORATORY
K951486 · DPW
Vasamedics, LLC
Cardiovascular · 91d
Cleared Jun 28, 1995
3050 DIASCOPE NT PATIENT MONITOR
K942196 · DSI
S & W Medico Teknik A/S
Cardiovascular · 420d
Cleared Jun 28, 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · DPS
Quinton, Inc.
Cardiovascular · 224d
Cleared Jun 28, 1995
Kaplan-Simpson InfusaSleeve II Catheter
K952317 · QEY
Localmed, Inc.
Cardiovascular · 42d
Cleared Jun 27, 1995
FLEXFINDER GUIDEWIRE
K943390 · DQX
Flexmedics
Cardiovascular · 348d
Cleared Jun 27, 1995
DIDECO PEDIATRIC ARTERIAL FILTERS
K945198 · DTM
Sorin Biomedical, Inc.
Cardiovascular · 246d
Cleared Jun 27, 1995
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 181d
Cleared Jun 27, 1995
MEDAMICUS PERCUTANEOUS INTRODUCER
K951313 · DYB
Medamicus, Inc.
Cardiovascular · 96d
Cleared Jun 26, 1995
MEMORYTRACE ATM MODEL 4222
K941898 · DXH
Hi-Tronics Designs, Inc.
Cardiovascular · 434d
Cleared Jun 23, 1995
DYNAPULSE 5000A (DP5000A)
K945111 · DXN
Pulse Metric, Inc.
Cardiovascular · 248d
Cleared Jun 22, 1995
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE
K950216 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1995
BRAUN PTA BALLOON CATHETER
K951248 · LIT
B.Braun Medical, Inc.
Cardiovascular · 94d
Cleared Jun 22, 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · DQX
Baxter Healthcare Corp
Cardiovascular · 92d
Cleared Jun 22, 1995
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM
K951508 · DTK
Boston Scientific Corp
Cardiovascular · 80d
Cleared Jun 22, 1995
SCIMED EXPO ANGIOGRAPHIC CATHETER
K951720 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Jun 21, 1995
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K941473 · DTZ
Medtronic Vascular
Cardiovascular · 450d
Cleared Jun 21, 1995
BRAUN MANIFOLD
K942391 · DTL
B.Braun Medical, Inc.
Cardiovascular · 398d
Cleared Jun 21, 1995
COWBOY X
K944567 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 275d
Cleared Jun 21, 1995
EVOLUTION(TM) MICROCATHETER
K945666 · KRA
Boston Scientific Corp
Cardiovascular · 216d
Cleared Jun 21, 1995
LEMAITRE VALVULOTOME II
K946352 · MGZ
Vascutech, Inc.
Cardiovascular · 173d