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
10297–10320 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 10, 1996
ESORT II + 400 SERIES MONITOR
K961138 · DRO
Medical Data Electronics
Cardiovascular · 264d
Cleared Dec 10, 1996
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
K961223 · LOS
Criticare Systems, Inc.
Cardiovascular · 256d
Cleared Dec 09, 1996
MEDICOTEST ECG ELECTRODES
K961643 · DRX
Medicotest, Inc.
Cardiovascular · 224d
Cleared Dec 09, 1996
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
K961937 · DQD
Delphi Consulting Group
Cardiovascular · 203d
Cleared Dec 05, 1996
GISH RELIANCE OXYGENATOR (MODEL HFO)
K961530 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 227d
Cleared Dec 04, 1996
STETHOS
K963621 · DQD
Theratechnologies, Inc.
Cardiovascular · 89d
Cleared Dec 04, 1996
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
K963811 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 72d
Cleared Dec 03, 1996
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL...
K960970 · MCW
Possis Medical, Inc.
Cardiovascular · 267d
Cleared Dec 03, 1996
TFX MEDICAL GUIDEWIRE
K963320 · DQX
Tfx Medical Group
Cardiovascular · 102d
Cleared Nov 26, 1996
BIOZ SYSTEM
K963183 · DSB
Cardiodynamics International Corp.
Cardiovascular · 104d
Cleared Nov 26, 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200...
K963400 · DPS
Nellcor Puritan Bennett, Inc.
Cardiovascular · 89d
Cleared Nov 25, 1996
TRACE RITE SOLID GEL ECG ELECTRODES
K964213 · DRX
Bio-Detek, Inc.
Cardiovascular · 34d
Cleared Nov 21, 1996
VITALMAX 4000/MINIPACK 3100/3000
K951226 · DSK
Pace Tech, Inc.
Cardiovascular · 612d
Cleared Nov 21, 1996
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
K962128 · DXG
Hemo Sapiens, Inc.
Cardiovascular · 171d
Cleared Nov 21, 1996
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT...
K963611 · DXZ
Vascutek, Ltd.
Cardiovascular · 72d
Cleared Nov 20, 1996
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
K961917 · DQX
Medtronics Interventional Vascular
Cardiovascular · 187d
Cleared Nov 19, 1996
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · DYG
Boston Scientific Scimed, Inc.
Cardiovascular · 181d
Cleared Nov 19, 1996
CARDIOSERV S
K962551 · LDD
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Nov 19, 1996
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
K962771 · DWS
Pilling Weck, Inc.
Cardiovascular · 126d
Cleared Nov 19, 1996
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151 · DRX
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 18, 1996
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K963014 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 108d
Cleared Nov 18, 1996
SIMON NITINOL FILTER SYSTEM
K963016 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 108d
Cleared Nov 15, 1996
HEARTPORT MULTIFIRE CLIP APPLIER
K961333 · DSS
Heartport, Inc.
Cardiovascular · 221d
Cleared Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · DSP
Datascope Corp.
Cardiovascular · 210d