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
9553–9576 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 08, 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Mar 05, 1999
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
K981702 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 295d
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
K981431 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 317d
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
K981542 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 308d
Cleared Mar 02, 1999
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
K964235 · DXN
Industrielle Entwicklung...
Cardiovascular · 860d
Cleared Mar 02, 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · DTP
Dideco S.P.A.
Cardiovascular · 89d
Cleared Feb 26, 1999
7F HYDROLYSER THROMBECTOMY CATHETER
K983534 · QEZ
Cordis Corp.
Cardiovascular · 140d
Cleared Feb 26, 1999
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
K990106 · MKJ
Bio-Detek, Inc.
Cardiovascular · 45d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Boston Scientific Corp
Cardiovascular · 232d
Cleared Feb 23, 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · DXC
Radi Medical Systems AB
Cardiovascular · 144d
Cleared Feb 22, 1999
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K984150 · DRF
Ep Medsystems
Cardiovascular · 95d
Cleared Feb 22, 1999
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K984294 · DSY
Intervascular, Inc.
Cardiovascular · 83d
Cleared Feb 22, 1999
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250
K990380 · DXN
Meditec Co., Ltd.
Cardiovascular · 14d
Cleared Feb 19, 1999
E-FAX SYSTEM
K982034 · DXH
Blakbag, Ltd., Division of Coherent...
Cardiovascular · 254d
Cleared Feb 19, 1999
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · IZQ
Nycomed Amersham Imaging
Cardiovascular · 151d
Cleared Feb 17, 1999
BIPORE BALLOON DILATATION CATHETER
K983650 · LIT
Bipore, Inc.
Cardiovascular · 124d
Cleared Feb 16, 1999
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
K984089 · DSI
Zymed Medical Instrumentation
Cardiovascular · 92d
Cleared Feb 12, 1999
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · MGZ
Vascutech, Inc.
Cardiovascular · 353d
Cleared Feb 11, 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · IZQ
Acist Medical Systems
Cardiovascular · 90d
Cleared Feb 11, 1999
NEUROVASX SUB-MICROINFUSION CATHETER
K984258 · DQO
Neuro Vasx, Inc.
Cardiovascular · 73d
Cleared Feb 09, 1999
OMNICORDER, MODEL 464
K990027 · DSH
Del Mar Avionics
Cardiovascular · 35d
Cleared Feb 08, 1999
IQ SYSTEM
K981720 · DSB
Renaissance Technology, Inc.
Cardiovascular · 279d
Cleared Feb 05, 1999
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
K983372 · DRS
Sunscope Intl., Inc.
Cardiovascular · 134d
Cleared Feb 05, 1999
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
K983626 · DXH
Alaris Medical Systems, Inc.
Cardiovascular · 113d