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
9889–9912 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 26, 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 399d
Cleared Jan 26, 1998
CORONARY VEIN GRAFT TAG MARKER
K971966 · KPK
Med-Edge, Inc.
Cardiovascular · 243d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · DSP
Arrow Intl., Inc.
Cardiovascular · 392d
Cleared Jan 22, 1998
FORMULA FOR ARCHIMED
K974079 · DPS
Biosound Esaote, Inc.
Cardiovascular · 85d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS...
K974155 · DTN
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jan 20, 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · MSX
Hewlett-Packard Co.
Cardiovascular · 46d
Cleared Jan 16, 1998
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
K972242 · MXC
Medtronic Vascular
Cardiovascular · 214d
Cleared Jan 16, 1998
RECHARGEABLE BATTERY PART NUMBER GL825-200
K974061 · DXN
Alexander Mfg. Co.
Cardiovascular · 81d
Cleared Jan 13, 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 307d
Cleared Jan 13, 1998
MAGLIFE C
K972535 · MHX
Odam
Cardiovascular · 189d
Cleared Jan 13, 1998
SINGLE LUMEN EMBOLECTOMY CATHETER
K972572 · DXE
American Biomed, Inc.
Cardiovascular · 187d
Cleared Jan 13, 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 90d
Cleared Jan 12, 1998
EZ HOLD 1 LBS., EZ HOLD 2 LBS
K973132 · DXC
Tz Medical, Inc.
Cardiovascular · 144d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 09, 1998
LIFE PAK 12
K973486 · MKJ
Physio-Control Corp.
Cardiovascular · 116d
Cleared Jan 08, 1998
STELA MODEL UJ45 PACING LEADS
K972574 · DTB
Ela Medical, Inc.
Cardiovascular · 182d
Cleared Jan 08, 1998
AMBULATORY X-12 TELEMETRY MODULE
K974149 · DRG
Mortara Instrument, Inc.
Cardiovascular · 65d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Jan 02, 1998
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
K970629 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 317d
Cleared Jan 02, 1998
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
K973863 · DXH
Hi-Tronics Designs, Inc.
Cardiovascular · 85d
Cleared Dec 30, 1997
SENTINEL RECORDER, MODELS 471/472
K971696 · DXH
Del Mar Avionics
Cardiovascular · 236d
Cleared Dec 29, 1997
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
K971570 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 244d
Cleared Dec 29, 1997
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K971775 · LDF
Cardiac Control Systems, Inc.
Cardiovascular · 230d
Cleared Dec 29, 1997
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
K973873 · DRG
American Telecare, Inc.
Cardiovascular · 80d