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
9145–9168 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815 · MHX
Datex-Ohmeda
Cardiovascular · 87d
Cleared Jun 08, 2000
ALLON 2001
K001546 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 21d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN...
K001602 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Jun 08, 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K991137 · DTR
Minntech Corp.
Cardiovascular · 430d
Cleared Jun 08, 2000
ENGAGE JAW INSERTS
K992980 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 279d
Cleared Jun 07, 2000
AGILENT M2636A TELEMON MONITOR
K001436 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2000
ENSITE 3000 SYSTEM, MODEL EE3000
K001437 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT)...
K001454 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Jun 07, 2000
CIPA (ADULTS) CIPI (INFANTS)
K992932 · DWF
Dmc Medical, Ltd.
Cardiovascular · 281d
Cleared Jun 05, 2000
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
K000820 · DQO
Endosonics Corp.
Cardiovascular · 84d
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882 · MHX
Datex-Ohmeda
Cardiovascular · 77d
Cleared Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...
K993772 · DTZ
Terumo Medical Corp.
Cardiovascular · 210d
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · DTB
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared May 31, 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared May 31, 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · DXT
Invasatec
Cardiovascular · 553d
Cleared May 31, 2000
MODIFICATION TO ACIST CL 100H
K991103 · DXT
Acist Medical Systems
Cardiovascular · 426d
Cleared May 26, 2000
DINAMAP ADVANCED NIBP MODULE
K000500 · DXN
Critikon Company, LLC
Cardiovascular · 102d
Cleared May 26, 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
K992668 · DYB
Innerdyne, Inc.
Cardiovascular · 291d
Cleared May 24, 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · DPS
General Electric Medical Systems...
Cardiovascular · 89d
Cleared May 24, 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
K001346 · DYB
St. Jude Medical, Inc.
Cardiovascular · 26d
Cleared May 23, 2000
CARDTEL, MODEL NT-100
K000609 · MWJ
Cardiac Telecommunications
Cardiovascular · 90d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · DSP
Arrow Intl., Inc.
Cardiovascular · 74d