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
11497–11520 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 1993
DATASCOPE 6000 MONITOR
K926099 · MLC
Datascope Corp.
Cardiovascular · 246d
Cleared Aug 06, 1993
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
K930057 · DYB
B.Braun Medical, Inc.
Cardiovascular · 212d
Cleared Aug 06, 1993
TC2000 POWER UNIT AND ACCESSORIES
K930345 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 193d
Cleared Aug 06, 1993
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE
K932835 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 57d
Cleared Aug 05, 1993
ROTATOR
K932251 · DTR
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Aug 03, 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · DSP
Datascope Corp.
Cardiovascular · 547d
Cleared Aug 03, 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · DTB
Medtronic Vascular
Cardiovascular · 85d
Cleared Aug 02, 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · DSP
Datascope Corp.
Cardiovascular · 958d
Cleared Aug 02, 1993
MEDI-DYNE ANGIOGRAPHIC CATHETER
K930694 · DQO
Medi-Dyne, Inc.
Cardiovascular · 173d
Cleared Jul 30, 1993
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
K925744 · DXQ
Pymah Corp.
Cardiovascular · 259d
Cleared Jul 29, 1993
CARDIAX
K924544 · DPS
Fairlake Marketing Group, Inc.
Cardiovascular · 324d
Cleared Jul 29, 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · DQO
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jul 28, 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · KFM
3M Health Care, Ltd.
Cardiovascular · 609d
Cleared Jul 27, 1993
SITERITE NEEDLE GUIDE (MODIFIED)
K931403 · DQY
Dymax Corp
Cardiovascular · 130d
Cleared Jul 21, 1993
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285 · DQK
B. Braun of America, Inc.
Cardiovascular · 274d
Cleared Jul 21, 1993
WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
K930888 · DRS
Ralin Medical, Inc.
Cardiovascular · 152d
Cleared Jul 21, 1993
COWBOY III
K932215 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 75d
Cleared Jul 20, 1993
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
K920429 · MLD
Hewlett-Packard Co.
Cardiovascular · 533d
Cleared Jul 20, 1993
CC ARHYTHMIS MONITORING OPTION
K923747 · DSI
Hewlett-Packard Co.
Cardiovascular · 376d
Cleared Jul 19, 1993
CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
K925444 · DYG
Ami-Med Corp.
Cardiovascular · 264d
Cleared Jul 14, 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327 · DQX
Peripheral Systems Group
Cardiovascular · 120d
Cleared Jul 13, 1993
TROPIC-AIR
K923104 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 383d
Cleared Jul 13, 1993
HE-30 GOLD
K931967 · DTR
Bentley Laboratories, Inc.
Cardiovascular · 83d
Cleared Jul 09, 1993
CARDIO-PAK BASIC PUMP PACK
K923231 · DWE
Cardio-Med-Associates, Inc.
Cardiovascular · 373d