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
9313–9336 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · DYB
Boston Scientific Corp
Cardiovascular · 18d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 89d
Cleared Dec 29, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
K993542 · DXN
Rossmax International , Ltd.
Cardiovascular · 71d
Cleared Dec 28, 1999
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08,...
K991541 · DWF
A-Med Systems, Inc.
Cardiovascular · 239d
Cleared Dec 28, 1999
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · MWJ
Nexan Telemed , Ltd.
Cardiovascular · 61d
Cleared Dec 21, 1999
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173 · DQO
Maxxim Medical
Cardiovascular · 336d
Cleared Dec 21, 1999
CG-2100 ECG TRANSMITTER
K994009 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 25d
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121 · KRD
Cook, Inc.
Cardiovascular · 180d
Cleared Dec 20, 1999
INTERFACE MODULE IDDD
K992635 · KRI
Stoeckert Instrumente
Cardiovascular · 136d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · DRG
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Dec 20, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
K993432 · DXN
Rossmax International , Ltd.
Cardiovascular · 69d
Cleared Dec 20, 1999
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
K993888 · DXN
A&D Engineering, Inc.
Cardiovascular · 34d
Cleared Dec 17, 1999
YP 45/15-BP
K993139 · DTB
Biotronik, Inc.
Cardiovascular · 88d
Cleared Dec 15, 1999
QMS MAPPING SYSTEM,MODEL 2000
K990058 · DQK
Cathdata, Inc.
Cardiovascular · 342d
Cleared Dec 12, 1999
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
K983250 · DSK
Magnetic Resonance Equipment Corp.
Cardiovascular · 452d
Cleared Dec 10, 1999
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 204d
Cleared Dec 10, 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · DQD
Bio-Research Associates, Inc.
Cardiovascular · 200d
Cleared Dec 10, 1999
LUMA-CATH STEERABLE EP CATHETERS
K991878 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 191d
Cleared Dec 10, 1999
CHEST DRAINAGE TUBING
K993062 · DWE
Olson Medical Sales, Inc.
Cardiovascular · 88d
Cleared Dec 10, 1999
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
K993072 · MKJ
Survivalink Corp.
Cardiovascular · 87d
Cleared Dec 10, 1999
CG-7000DX ECG RECORDER/TRANSMITTER
K993799 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 31d
Cleared Dec 09, 1999
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K990503 · DSY
Sulzermedica
Cardiovascular · 295d
Cleared Dec 09, 1999
LEMAITRE EMBOLECTOMY CATHETER
K992368 · DXE
Vascutech, Inc.
Cardiovascular · 147d
Cleared Dec 08, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT...
K992595 · MHX
Hewlett-Packard GmbH
Cardiovascular · 127d