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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
12025–12048 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 171d
Cleared Dec 09, 1991
FUKUDA DENSHI MODEL FCP-4101
K913811 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 105d
Cleared Dec 09, 1991
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · LDD
Medical Data Electronics
Cardiovascular · 63d
Cleared Dec 06, 1991
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER
K914009 · DQO
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 05, 1991
SYSTEM ATHENA - PRODUCT ENHANCEMENTS
K912049 · DRT
S & W Medico Teknik
Cardiovascular · 240d
Cleared Dec 05, 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
K912293 · DQX
Target Therapeutics
Cardiovascular · 196d
Cleared Dec 05, 1991
MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR
K914762 · DPS
Micromed
Cardiovascular · 44d
Cleared Dec 04, 1991
TYPE 9210 S/ECG
K903940 · DSI
S & W Medico Teknik
Cardiovascular · 464d
Cleared Dec 04, 1991
SAFE II
K912082 · DTZ
Polystan A/S
Cardiovascular · 208d
Cleared Dec 04, 1991
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
K912188 · MHX
Critikon Company, LLC
Cardiovascular · 201d
Cleared Dec 04, 1991
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · DTR
Medtronic Vascular
Cardiovascular · 84d
Cleared Dec 04, 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 47d
Cleared Nov 29, 1991
DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER
K911883 · DYB
Diag Corp.
Cardiovascular · 214d
Cleared Nov 27, 1991
VESSEL DILATOR
K913027 · DRE
Deseret Medical, Inc.
Cardiovascular · 141d
Cleared Nov 27, 1991
BARD(R) BIOPOTENTIAL AMPLIFIER II
K913875 · DRQ
Bard Electrophysiology
Cardiovascular · 90d
Cleared Nov 27, 1991
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · DSY
Medtronic Vascular
Cardiovascular · 83d
Cleared Nov 27, 1991
CONNECTING SET
K914128 · DQO
Procedure Products, Inc.
Cardiovascular · 75d
Cleared Nov 25, 1991
FLOSWITCH(R) HP
K913871 · DQO
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 22, 1991
ITC GUIDING CATHETER
K913052 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 136d
Cleared Nov 22, 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Nov 22, 1991
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · DRB
Target Therapeutics
Cardiovascular · 77d
Cleared Nov 22, 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 57d
Cleared Nov 22, 1991
CORDIS OBTURATOR
K914352 · DYB
Cordis Corp.
Cardiovascular · 53d
Cleared Nov 22, 1991
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · DRF
Medtronic Vascular
Cardiovascular · 46d