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
12865–12888 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 07, 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377 · DTL
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · DXO
Millar Instruments, Inc.
Cardiovascular · 73d
Cleared Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · LDF
Medtronic Vascular
Cardiovascular · 70d
Cleared Dec 05, 1989
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · DYB
Boston Scientific Corp
Cardiovascular · 278d
Cleared Dec 05, 1989
ECG SIMULATOR MODEL ECGPLUS
K893660 · DPS
Bio-Tek Instruments, Inc.
Cardiovascular · 204d
Cleared Dec 04, 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · DTZ
3M Company
Cardiovascular · 90d
Cleared Dec 01, 1989
STETH-SHIELD(TM)
K892890 · DQD
North East Technology
Cardiovascular · 225d
Cleared Nov 30, 1989
SPACELABS MODEL 90900
K894093 · LOS
Spacelabs, Inc.
Cardiovascular · 174d
Cleared Nov 30, 1989
ANGEION HEMOSTASIS VALVE INTRODUCER
K894446 · DYB
Angeion Corp.
Cardiovascular · 136d
Cleared Nov 30, 1989
SCD KNEE IMMOBILIZER
K895278 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 99d
Cleared Nov 29, 1989
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · DWF
Kendall Healthcare Products Co....
Cardiovascular · 89d
Cleared Nov 29, 1989
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · DQY
Quinton, Inc.
Cardiovascular · 85d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
K895428 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 27, 1989
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
K893678 · KRH
Medtronic Blood Systems, Inc.
Cardiovascular · 195d
Cleared Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · DQO
Baxter Healthcare Corp
Cardiovascular · 165d
Cleared Nov 15, 1989
V*S*R(TM) SCOPE
K895545 · LDE
Vsr Enterprises Corp.
Cardiovascular · 63d
Cleared Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 204d
Cleared Nov 14, 1989
HEMOSTASIS VALVE
K895214 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Nov 14, 1989
SELDINGER SINGLE WALL
K895454 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
SELDINGER PERCUTANEOUS 2 PC NEEDLES
K895455 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
BREVET DISPOSABLE CONNECTORS
K895753 · DQY
Brevet, Inc.
Cardiovascular · 49d
Cleared Nov 08, 1989
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
K892856 · KRI
Acacia Laboratories, Inc.
Cardiovascular · 204d
Cleared Nov 06, 1989
CCO SYSTEM MODEL SP1467,SP5567,SP6267
K892941 · KRB
Spectramed, Inc.
Cardiovascular · 199d