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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11377–11400 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Jul 09, 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
K930787 · DQX
Advanced Surgical, Inc.
Cardiovascular · 143d
Cleared Jul 08, 1993
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)
K924208 · DPT
Medtronic Bio-Medicus, Inc.
Cardiovascular · 322d
Cleared Jul 01, 1993
CRITIKON VITAL SIGNS MODULE
K915697 · DXN
Critikon Company, LLC
Cardiovascular · 556d
Cleared Jul 01, 1993
BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
K921048 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 484d