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
12889–12912 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
K895268 · DQO
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Nov 03, 1989
CMS VRB-1200
K895076 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 81d
Cleared Nov 03, 1989
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · DRX
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Nov 02, 1989
BIO-CAL 370 HEATER/COOLER
K894980 · DWJ
Bio Medicus, Inc.
Cardiovascular · 86d
Cleared Nov 01, 1989
BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
K892641 · DTZ
Bard Cardiosurgery Div
Cardiovascular · 203d
Cleared Nov 01, 1989
NANOS
K894239 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 134d
Cleared Nov 01, 1989
DATASCOPE STEERING HANDLE
K894940 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Nov 01, 1989
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K894970 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Oct 30, 1989
E-RAM
K884126 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 395d
Cleared Oct 30, 1989
1100 VITAL SIGNS MONITOR
K884643 · DSI
Criticare Systems, Inc.
Cardiovascular · 357d
Cleared Oct 30, 1989
SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
K892323 · DSB
Seismed Instruments, Inc.
Cardiovascular · 207d
Cleared Oct 30, 1989
BIOPSY FORCEPS
K895098 · DWZ
Annex Medical, Inc.
Cardiovascular · 76d
Cleared Oct 27, 1989
HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM
K894892 · DSB
Koven and Assoc., Inc.
Cardiovascular · 87d
Cleared Oct 27, 1989
FIRST MEDIC MODEL 610P
K895185 · LDD
First Medical Devices Corp.
Cardiovascular · 77d
Cleared Oct 26, 1989
NEOS 02
K894240 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 128d
Cleared Oct 26, 1989
DEFIB/PACING PADS
K894588 · DRO
Conmedcorp
Cardiovascular · 94d
Cleared Oct 26, 1989
PAQ10 PAPER CHART RECORDER
K894607 · DSF
Protocol Systems, Inc.
Cardiovascular · 98d
Cleared Oct 26, 1989
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · DXN
Marquette Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 26, 1989
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Oct 26, 1989
COORDINATOR
K895113 · LDD
Cardiotronics, Inc.
Cardiovascular · 72d
Cleared Oct 20, 1989
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · DTZ
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 20, 1989
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
K894721 · DWE
The Traumafuse Co.
Cardiovascular · 87d
Cleared Oct 19, 1989
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · DXK
Toshiba America Medical Systems, In.C
Cardiovascular · 87d
Cleared Oct 17, 1989
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K890875 · DPS
Ppg Industries, Inc.
Cardiovascular · 238d