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
10225–10248 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 04, 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125 · DRX
Contour Medical Technology, Inc.
Cardiovascular · 49d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · DRO
Marquette Electronics, Inc.
Cardiovascular · 200d
Cleared Feb 28, 1997
CARDIACMONITOR
K963375 · DXH
Vision Electronics
Cardiovascular · 185d
Cleared Feb 28, 1997
MOBILE MEDICAL MONITOR (M3(A))
K963576 · DRT
Scientific Applications
Cardiovascular · 175d
Cleared Feb 28, 1997
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
K964888 · DXH
Tz Medical, Inc.
Cardiovascular · 84d
Cleared Feb 26, 1997
BERENSTEIN COIL
K964112 · KRD
Target Therapeutics
Cardiovascular · 134d
Cleared Feb 25, 1997
CAPIOX SP PUMP HEAD
K962981 · KFM
Terumo Medical Corp.
Cardiovascular · 208d
Cleared Feb 24, 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827 · DSI
Marquette Electronics, Inc.
Cardiovascular · 220d
Cleared Feb 24, 1997
CARETONE II
K963678 · DQD
American Telecare, Inc.
Cardiovascular · 164d
Cleared Feb 21, 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS)...
K962765 · DQX
Cordis Corp.
Cardiovascular · 220d
Cleared Feb 21, 1997
EAGLE 4000 PATIENT MONITOR
K964750 · LOS
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Feb 21, 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249 · DQO
Daig Corp.
Cardiovascular · 71d
Cleared Feb 20, 1997
MAXI LD PTA BALLOON CATHETER
K963000 · LIT
Cordis Corp.
Cardiovascular · 202d
Cleared Feb 20, 1997
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · LYK
W.L. Gore & Associates, Inc.
Cardiovascular · 133d
Cleared Feb 19, 1997
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665 · DSY
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Feb 18, 1997
PROTECT ALL BLOOD PRESSURE CUFF COVER
K964648 · DXQ
Protect All, Inc.
Cardiovascular · 90d
Cleared Feb 14, 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · KRH
St. Jude Medical, Inc.
Cardiovascular · 319d
Cleared Feb 12, 1997
6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE...
K962717 · DQY
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 215d
Cleared Feb 11, 1997
AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
K964697 · DXN
Advance Medical Device, Inc.
Cardiovascular · 81d
Cleared Feb 10, 1997
HEARTPORT ENDOVENOUS DRAINAGE CANNULA
K962835 · DWF
Heartport, Inc.
Cardiovascular · 203d
Cleared Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Feb 06, 1997
AS/3 ESTPR MODULE
K953175 · MLD
Datex Division Instrumentarium Corp.
Cardiovascular · 580d
Cleared Feb 04, 1997
SAFE MICRO
K953976 · DTZ
Polystan A/S
Cardiovascular · 531d
Cleared Feb 04, 1997
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104 · DSP
Arrow Intl., Inc.
Cardiovascular · 179d