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
11809–11832 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 26, 1992
E350I ELECTROCARDIOGRAPH
K914969 · LOS
Siemens Burdick, Inc.
Cardiovascular · 142d
Cleared Mar 23, 1992
TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
K915521 · DQY
Target Therapeutics
Cardiovascular · 144d
Cleared Mar 19, 1992
OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.
K910929 · DSI
Ohmeda Medical
Cardiovascular · 380d
Cleared Mar 18, 1992
USCI HEMAQUET XT INTRODUCER
K920251 · DYB
C.R. Bard, Inc.
Cardiovascular · 57d
Cleared Mar 17, 1992
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · DPS
Biosound, Inc.
Cardiovascular · 49d
Cleared Mar 17, 1992
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
K920530 · DXY
Intermedics, Inc.
Cardiovascular · 41d
Cleared Mar 16, 1992
DUAL BALLOON EMBOLECTOMY CATHETER
K914880 · DXE
Ideal Medical, Inc.
Cardiovascular · 138d
Cleared Mar 16, 1992
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157 · DXY
Schneider Intl., Ltd.
Cardiovascular · 62d
Cleared Mar 11, 1992
DATASCOPE SYSTEM 95
K912629 · DSP
Datascope Corp.
Cardiovascular · 268d
Cleared Mar 11, 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · DSP
Datascope Corp.
Cardiovascular · 197d
Cleared Mar 09, 1992
DIAGNOSTIC EP CATHETER
K915563 · DRF
Arrhythmia Technologies, Inc.
Cardiovascular · 88d
Cleared Mar 09, 1992
VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER
K915640 · DRF
Arrhythmia Technologies, Inc.
Cardiovascular · 83d
Cleared Mar 09, 1992
GYMMAN
K920099 · DRT
Lumiscope Co., Inc.
Cardiovascular · 60d
Cleared Mar 04, 1992
NGM NIBP MODULE
K911645 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 324d
Cleared Mar 04, 1992
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · DRF
Daig Corp.
Cardiovascular · 162d
Cleared Mar 04, 1992
GEMSCOM SERIES 3000
K914889 · DRG
General Devices
Cardiovascular · 125d
Cleared Mar 04, 1992
SARNS RETROGRADE CANNULA
K915193 · DWF
3M Health Care, Sarns
Cardiovascular · 106d
Cleared Mar 02, 1992
OPTICAL VALVULOTOME
K914385 · MGZ
Intramed Laboratories, Inc.
Cardiovascular · 153d
Cleared Feb 27, 1992
ALTAIR
K912728 · DQK
Diagnostic Medical Instruments
Cardiovascular · 252d
Cleared Feb 27, 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
K914531 · DQX
Arrow Intl., Inc.
Cardiovascular · 139d
Cleared Feb 27, 1992
GUIDEWIRE INTRODUCER SET
K915421 · DYB
B. Braun of America, Inc.
Cardiovascular · 87d
Cleared Feb 27, 1992
DESERET GUIDEWIRE INTRODUCER
K915496 · DQX
Bd Becton Dickinson Vacutainer...
Cardiovascular · 80d
Cleared Feb 26, 1992
CATHWRITER(TM)
K914105 · DQK
Softheart, Inc.
Cardiovascular · 166d
Cleared Feb 26, 1992
PIKOS 01 & PIKOS E 01
K914109 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 166d