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
7249–7272 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 24, 2005
BPCALIBRATOR MC3000/MC3100
K051546 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 11d
Cleared Jun 23, 2005
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K051283 · MSX
Cardiopulmonary Corp.
Cardiovascular · 37d
Cleared Jun 23, 2005
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374 · DQX
Stereotaxis, Inc.
Cardiovascular · 28d
Cleared Jun 22, 2005
PERIPHERAL CUTTING BALLOON
K051254 · PNO
Boston Scientific Ivt
Cardiovascular · 37d
Cleared Jun 21, 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · LIT
Abbott Laboratories (Perclose, Inc.)
Cardiovascular · 13d
Cleared Jun 20, 2005
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
K050995 · OBJ
Volcano Corporation
Cardiovascular · 61d
Cleared Jun 20, 2005
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
K051021 · DXQ
Shanghai Lord International Trade...
Cardiovascular · 59d
Cleared Jun 20, 2005
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
K051367 · MHX
Ge Medical Systems Information...
Cardiovascular · 26d
Cleared Jun 17, 2005
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456 · DXT
Medrad, Inc.
Cardiovascular · 114d
Cleared Jun 15, 2005
LYSUS INFUSION SYSTEM
K051319 · QEY
Ekos Corp.
Cardiovascular · 26d
Cleared Jun 14, 2005
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P,...
K050919 · DSI
Analogic Corp.
Cardiovascular · 63d
Cleared Jun 14, 2005
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K051220 · NLH
Sterilmed, Inc.
Cardiovascular · 33d
Cleared Jun 13, 2005
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · OCL
AtriCure, Inc.
Cardiovascular · 110d
Cleared Jun 13, 2005
PV 1900 SYNCHRO 0.016 GUIDEWIRE
K050964 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 56d
Cleared Jun 10, 2005
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
K051228 · DSB
Cardiodynamics International Corp.
Cardiovascular · 28d
Cleared Jun 10, 2005
BIO-CONSOLE, MODEL 560
K051303 · DWA
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Jun 08, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
K050916 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 57d
Cleared Jun 08, 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · NFA
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 08, 2005
REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
K051470 · DRG
Bl Healthcare, Inc.
Cardiovascular · 5d
Cleared Jun 07, 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
K050371 · DQO
Medrad, Inc.
Cardiovascular · 113d
Cleared Jun 07, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
K050915 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 56d
Cleared Jun 06, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K051043 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 42d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599 · DQY
Boston Scientific Corp
Cardiovascular · 86d
Cleared Jun 01, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K050763 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 69d