FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15385–15408 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 03, 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · DTD
Pacesetter Systems
Cardiovascular · 98d
Cleared Aug 03, 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · DTD
Pacesetter Systems
Cardiovascular · 88d
Cleared Aug 03, 1984
CARDIOPLEGIA RESERVOIR CAS-2000
K841938 · DTN
American Bentley
Cardiovascular · 84d
Cleared Aug 03, 1984
MODEL 110-5 & 140-8
K842005 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Aug 03, 1984
CENTRIMED SYSTEM 1
K842007 · KFM
Centrimed Corp.
Cardiovascular · 78d
Cleared Aug 03, 1984
COBE EMERGENCY POWER SOURCE 43610-000
K842138 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Aug 03, 1984
SOLUTION CLARIFICATION UNIT
K842141 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 65d
Cleared Aug 03, 1984
AIR SHIELDS AS461 MONITORING SYS
K842321 · DRT
Air-Shields, Inc.
Cardiovascular · 52d
Cleared Aug 03, 1984
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · DYB
Medtronic Vascular
Cardiovascular · 18d
Cleared Aug 02, 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · DPS
Quinton, Inc.
Cardiovascular · 121d
Cleared Aug 02, 1984
COBE AEPS
K842054 · KRL
Cobe Laboratories, Inc.
Cardiovascular · 72d
Cleared Aug 01, 1984
AXIOM FEMORAL VENUS CATHETER
K842084 · DQY
Axiom Medical, Inc.
Cardiovascular · 69d
Cleared Aug 01, 1984
PCI W/CATH-SEAL SIDE FLOW FITTING
K842259 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 55d
Cleared Jul 30, 1984
COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
K843001
Cook Pacemaker Corp.
Cardiovascular
Cleared Jul 27, 1984
MONITOR ONE
K841172 · DSI
Qmed, Inc.
Cardiovascular · 130d
Cleared Jul 27, 1984
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822 · DRM
Keymed, Inc.
Cardiovascular · 86d
Cleared Jul 27, 1984
DRYDEN SCAVENGER INTERFACE SYSTEM
K842843
Dryden Corp.
Cardiovascular · 7d
Cleared Jul 20, 1984
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · DQY
Critikon Company, LLC
Cardiovascular · 38d
Cleared Jul 16, 1984
MINI-DOPPLER ES-100
K840542 · JOP
Hayashi Denki Co., Ltd.
Cardiovascular · 159d
Cleared Jul 13, 1984
SILVERTORQUE CEREBRAL CATHETER
K840762 · DQY
Surgimed Corp.
Cardiovascular · 141d
Cleared Jul 13, 1984
WEDGE PRESSURE CATHETER FLOW DIRECTED
K841705 · DYG
Mansfield Scientific, Inc.
Cardiovascular · 81d
Cleared Jul 13, 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 71d
Cleared Jul 13, 1984
POLYURETHANE THERMAL DILUTION CATHET
K841876 · DYG
Waters Instruments, Inc.
Cardiovascular · 67d
Cleared Jul 13, 1984
PERCUTANEOUS CATHETER INTRODUCER SET
K842004 · DYB
Aries Medical, Inc.
Cardiovascular · 58d