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
7681–7704 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784 · DRX
Bio Protech, Inc.
Cardiovascular · 9d
Cleared Apr 06, 2004
HRV TOOLS
K040313 · DPS
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 57d
Cleared Apr 05, 2004
SAFETYNET GUIDEWIRE INTRODUCER
K040029 · DYB
Injectimed, Inc.
Cardiovascular · 88d
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · DQY
Cook, Inc.
Cardiovascular · 109d
Cleared Apr 02, 2004
WELL@HOME SYSTEM
K040012 · DXN
Zoe Medical, Inc.
Cardiovascular · 88d
Cleared Mar 29, 2004
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
K040065 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 76d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2,...
K033050 · DRF
Medtronic Vascular
Cardiovascular · 179d
Cleared Mar 26, 2004
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
K034025 · DYB
Nmt Medical, Inc.
Cardiovascular · 88d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068 · KRD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS:...
K024213 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 459d
Cleared Mar 22, 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · DXN
Nonin Medical, Inc.
Cardiovascular · 315d
Cleared Mar 22, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 119d
Cleared Mar 22, 2004
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B
K034050 · DTK
Cordis Corporation
Cardiovascular · 83d
Cleared Mar 22, 2004
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
K040002 · DXN
Microlife Intellectual Property Gmb
Cardiovascular · 80d
Cleared Mar 22, 2004
APM BLOOD PRESSURE MONITOR, MODEL BP108A
K040159 · DXN
Asia Pacific Microsystems, Inc.
Cardiovascular · 59d
Cleared Mar 19, 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · DWF
Medtronic Perfusion Systems
Cardiovascular · 53d
Cleared Mar 19, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · DXN
A&D Engineering, Inc.
Cardiovascular · 46d
Cleared Mar 18, 2004
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
K040481 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 22d
Cleared Mar 16, 2004
CORRESTORE PATCH SYSTEM
K040162 · DXZ
Somanetics Corp.
Cardiovascular · 50d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · DXQ
Ethox Corp.
Cardiovascular · 38d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 35d
Cleared Mar 15, 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS...
K040355 · DTR
Gish Biomedical, Inc.
Cardiovascular · 32d
Cleared Mar 11, 2004
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
K033894 · DXN
Matsushita Electric Works, Ltd.
Cardiovascular · 86d
Cleared Mar 11, 2004
PROGREAT
K033913 · KRA
Terumo Medical Corp.
Cardiovascular · 85d