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
12937–12960 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 02, 1989
FUKUDA DENSHI MODEL FCP-2201
K892796 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Oct 02, 1989
HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM
K893094 · JOQ
Heartware Intl. Corp.
Cardiovascular · 157d
Cleared Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 153d
Cleared Oct 02, 1989
PCI MODEL 2041-A TELEMETRY MONITOR
K894340 · DXH
Accucore, Inc.
Cardiovascular · 80d
Cleared Oct 02, 1989
MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
K894445 · DYB
Mallinckroot, Inc.
Cardiovascular · 77d
Cleared Oct 02, 1989
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
K894460 · DSI
Siemens Medical Electronics
Cardiovascular · 76d
Cleared Oct 02, 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Oct 02, 1989
AP-851PA NIBP MODULE
K894693 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · DRT
S & W Medico Teknik
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · DRT
S & W Medico Teknik
Cardiovascular · 70d
Cleared Sep 28, 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · DQY
Target Therapeutics
Cardiovascular · 111d
Cleared Sep 28, 1989
OBTURATOR
K894157 · DYB
Argon Medical Corp.
Cardiovascular · 106d
Cleared Sep 27, 1989
VOSS GRAFT MARKER
K895369 · KPK
Voss Medical Products
Cardiovascular · 29d
Cleared Sep 26, 1989
EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
K890597 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 243d
Cleared Sep 26, 1989
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · DYG
Arrow Intl., Inc.
Cardiovascular · 168d
Cleared Sep 26, 1989
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
K893435 · DYG
Cathlab Corp.
Cardiovascular · 147d
Cleared Sep 26, 1989
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · DXH
Medtronic Vascular
Cardiovascular · 145d
Cleared Sep 26, 1989
FLEXMEDICS GUIDEWIRE
K893626 · DQX
Flexmedics
Cardiovascular · 138d
Cleared Sep 26, 1989
OPUS MODEL 4001
K894065 · DXY
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Sep 26, 1989
DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000
K894131 · DQY
Thermedics, Inc.
Cardiovascular · 105d
Cleared Sep 26, 1989
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
K894255 · KFM
St. Jude Medical, Inc.
Cardiovascular · 98d
Cleared Sep 26, 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · DXH
Hewlett-Packard Co.
Cardiovascular · 95d
Cleared Sep 26, 1989
DMI PC HOLTER SCANNER
K894285 · DSI
Diagnostic Medical Instruments
Cardiovascular · 95d
Cleared Sep 26, 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · DYB
Daig Corp.
Cardiovascular · 74d