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
11881–11904 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 17, 1992
LEOCOR GUIDING CATHETER
K911270 · DQO
Leocor, Inc.
Cardiovascular · 301d
Cleared Jan 17, 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 134d
Cleared Jan 15, 1992
MODIFIED SEISMOCARDIOGRAPH
K910994 · DSB
Seismed Instruments, Inc.
Cardiovascular · 318d
Cleared Jan 15, 1992
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · DRY
3M Company
Cardiovascular · 58d
Cleared Jan 15, 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265 · DRY
3M Company
Cardiovascular · 57d
Cleared Jan 13, 1992
COWBOY
K913611 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 152d
Cleared Jan 10, 1992
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
K914523 · DSS
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 92d
Cleared Jan 10, 1992
PROPAQ 102,104,106,102EL,104EL,&106EL
K914838 · MHX
Protocol Systems, Inc.
Cardiovascular · 77d
Cleared Jan 09, 1992
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077 · DTR
Dlp, Inc.
Cardiovascular · 182d
Cleared Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · KRH
Baxter Healthcare Corp
Cardiovascular · 64d
Cleared Jan 08, 1992
HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300
K911615 · DQK
Diagnostic Monitoring Software
Cardiovascular · 272d
Cleared Jan 08, 1992
HORIZON PACEMAKER DETECTION SOFTWARE
K913339 · DSI
Mennen Medical, Inc.
Cardiovascular · 166d
Cleared Jan 08, 1992
010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
K914828 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Jan 07, 1992
TC-1000, TC-1050 SYSTEM
K914805 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 75d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 06, 1992
HEART TECHNOLOGY WIRECLIP
K914581 · DQX
Heart Technology, Inc.
Cardiovascular · 82d
Cleared Jan 03, 1992
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · DRE
Med Institute, Inc.
Cardiovascular · 88d
Cleared Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665 · DRT
Ge Medical Systems Information...
Cardiovascular · 323d
Cleared Dec 31, 1991
UNIVERSAL TERMINAL CAP, 3.2MM
K913919 · KFJ
Telectronics Pacing Systems, Inc.
Cardiovascular · 119d
Cleared Dec 31, 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K914500 · LIT
Vas-Cath, Inc.
Cardiovascular · 84d
Cleared Dec 30, 1991
KELLER CARDIAC MONITOR MEDIL KMS870
K914576 · DRT
Keller Medical Specialties Products,...
Cardiovascular · 76d
Cleared Dec 27, 1991
SERIES 1500 12-LEAD ANALYSIS OPTION
K903644 · LOS
Marquette Electronics, Inc.
Cardiovascular · 501d