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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
10897–10920 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 31, 1995
HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER
K932388 · DRF
Heart Rhythm Technologies, Inc.
Cardiovascular · 744d
Cleared May 31, 1995
SCIMED GATEWAY PLUS
K951089 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared May 30, 1995
ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS
K950855 · DQO
Adam Spence Corp.
Cardiovascular · 92d
Cleared May 26, 1995
ECG FAX MODEM
K941282 · LOS
Hewlett-Packard Co.
Cardiovascular · 441d
Cleared May 25, 1995
QUEST ANTEGRADE CARDIOPLEGIA CANNULA
K950814 · DWF
Quest Medical, Inc.
Cardiovascular · 92d
Cleared May 25, 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared May 24, 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
K935877 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 531d
Cleared May 24, 1995
BSM-8800A BEDSIDE MONITOR
K944422 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 281d
Cleared May 24, 1995
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
K950687 · DSP
Belmont Instrument Corp.
Cardiovascular · 99d
Cleared May 23, 1995
TC 3000
K942881 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 340d
Cleared May 22, 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · DRO
Hewlett-Packard Co.
Cardiovascular · 108d
Cleared May 19, 1995
CARDIOVIT AT-5C
K941462 · LOS
Schiller America, Inc.
Cardiovascular · 421d
Cleared May 19, 1995
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K945065 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 217d
Cleared May 19, 1995
SCIMED(R) VENTURE(TM) II INFUSION CATHETER
K945904 · KRA
Scimed Peripheral Interventions
Cardiovascular · 168d
Cleared May 17, 1995
SPACELABS MEDICAL ECG MODULE (MODEL 90492)
K942058 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 383d
Cleared May 17, 1995
ECLIPSE 4 ELECTROCARDIOGRAPH
K943959 · LOS
Burdick, Inc.
Cardiovascular · 275d
Cleared May 17, 1995
TELPHONIC STETHOSCOPE
K945638 · DQD
American Telecare, Inc.
Cardiovascular · 182d
Cleared May 17, 1995
1700 MONITORING ECG ELECTRODE
K946273 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 146d
Cleared May 17, 1995
OPTA 5(TM) 5F PTA BALLOON CATHETER
K950119 · LIT
Cordis Corp.
Cardiovascular · 126d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486 · DRX
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · DRX
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
PICIS CHART+
K950536 · MHX
Picis
Cardiovascular · 99d
Cleared May 17, 1995
PULSE*SPRAY INFUSION SYSTEM
K950907 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 93d
Cleared May 16, 1995
TRANSIT-2 INFUSION CATHETER
K950909 · DQO
Cordis Neurovascular, Inc.
Cardiovascular · 91d