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
12097–12120 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 12, 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 108d
Cleared Aug 09, 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · DTB
Possis Medical, Inc.
Cardiovascular · 182d
Cleared Aug 09, 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · DTD
Biotronik, GmbH & Co.
Cardiovascular · 148d
Cleared Aug 09, 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · DTN
Shiley, Inc.
Cardiovascular · 102d
Cleared Aug 07, 1991
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830
K911049 · DXN
A&D Engineering, Inc.
Cardiovascular · 152d
Cleared Aug 07, 1991
PR4
K911097 · DSH
Mortara Instrument, Inc.
Cardiovascular · 148d
Cleared Aug 07, 1991
CUFFABLE
K911213 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 141d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UA-833
K912118 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212
K912119 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Jul 31, 1991
OMEGA ANGIOSCOPES (OMEGASCOPES)
K911090 · LYK
Omega Universal Technologies, Ltd.
Cardiovascular · 142d
Cleared Jul 31, 1991
ZOLL PD-1400 PACER/DEFIBRILLATOR
K911956 · DRO
Zmi Corp.
Cardiovascular · 90d
Cleared Jul 30, 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 168d
Cleared Jul 30, 1991
507 NON-INVASIVE VITAL SIGNS MONITOR
K910852 · DRT
Criticare Systems, Inc.
Cardiovascular · 153d
Cleared Jul 30, 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · DTD
Medtronic Vascular
Cardiovascular · 127d
Cleared Jul 30, 1991
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
K912051 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 82d
Cleared Jul 30, 1991
POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
K912076 · DQO
The R Group
Cardiovascular · 81d
Cleared Jul 30, 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · DXH
Medtronic Vascular
Cardiovascular · 78d
Cleared Jul 30, 1991
SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
K912191 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
SOFTTOUCH(R) GUIDING CATHETER
K912199 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
K-FREE
K912587 · LDD
Katecho, Inc.
Cardiovascular · 48d
Cleared Jul 26, 1991
MULTICHANNEL RECORDING SYSTEM
K912427 · DSH
Bionique
Cardiovascular · 56d
Cleared Jul 26, 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · DXY
Pace Medical
Cardiovascular · 46d
Cleared Jul 25, 1991
BLOOD PRESSURE CUFFS
K912638 · DXQ
Vital Signs, Inc.
Cardiovascular · 41d
Cleared Jul 25, 1991
RT40 RADIO TRANSLUCENT
K912714 · DRX
Bio-Detek, Inc.
Cardiovascular · 37d