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
10441–10464 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 15, 1996
PATHFINDER 700 HOLTER ANALYZER
K951902 · DQK
Reynolds Medical , Ltd.
Cardiovascular · 448d
Cleared Jul 15, 1996
3M RED DOT ECG LEAD WIRES A
K954900 · DSA
Minnesota Mining and Mfg. Co.
Cardiovascular · 264d
Cleared Jul 15, 1996
CARDIMAX MODEL FX-2111
K955416 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 231d
Cleared Jul 15, 1996
MAXIM PF MODELS 033-581/033-590
K961118 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 117d
Cleared Jul 11, 1996
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
K954163 · DXH
Cardiac Evaluation Center, Inc.
Cardiovascular · 310d
Cleared Jul 11, 1996
QUICKELS QS 200 SYSTEM
K954772 · DRX
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
QUICKELS QS 100 SYSTEM
K954773 · DRX
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
OMNI-TRAK PATIENT MONITORING SYSTEM
K955045 · DPS
Invivo Research, Inc.
Cardiovascular · 251d
Cleared Jul 10, 1996
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
K961362 · DXH
Aerotel, Ltd.
Cardiovascular · 92d
Cleared Jul 09, 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445 · DQX
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Jul 08, 1996
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 203d
Cleared Jul 03, 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Jul 03, 1996
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · DQD
Graham-Field, Inc.
Cardiovascular · 50d
Cleared Jul 02, 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · DPS
Nellcor Puritan Bennett, Inc.
Cardiovascular · 203d
Cleared Jul 02, 1996
INTROSTAT LEAD INTRODUCER
K960200 · DYB
Msi, Inc.
Cardiovascular · 181d
Cleared Jul 02, 1996
A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR
K960319 · DXN
A&D Engineering, Inc.
Cardiovascular · 161d
Cleared Jul 02, 1996
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
K960329 · MKJ
Contour Medical Technology, Inc.
Cardiovascular · 160d
Cleared Jul 02, 1996
PERCUGLIDE
K960917 · DRE
Scientific Device Manufacturer, LLC
Cardiovascular · 118d
Cleared Jul 02, 1996
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
K961358 · DSP
Arrow Intl., Inc.
Cardiovascular · 85d
Cleared Jun 28, 1996
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
K942227 · DSB
C.L. Mcintosh & Assoc., Inc.
Cardiovascular · 784d
Cleared Jun 27, 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · DQX
C.R. Bard, Inc.
Cardiovascular · 86d
Cleared Jun 27, 1996
MX960 REUSABLE PRESSURE TRANSDUCER
K961404 · DRS
Medex, Inc.
Cardiovascular · 77d
Cleared Jun 26, 1996
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER...
K961232 · DQX
Biocompatibles , Ltd.
Cardiovascular · 89d
Cleared Jun 26, 1996
DANESHVAR'S DEVICE (MODIFICATION)
K961461 · DXC
Y. Daneshvar
Cardiovascular · 85d