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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
9049–9072 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 21, 2000
ZYBIT
K002004 · DXH
Zymed Medical Instrumentation
Cardiovascular · 80d
Cleared Sep 21, 2000
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
K002029 · DXN
Zoll Medical Corp
Cardiovascular · 80d
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · DXN
Critikon Company, LLC
Cardiovascular · 58d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 18, 2000
QUEST MPS BACK-UP SYSYEM
K002366 · DWF
Quest Medical, Inc.
Cardiovascular · 53d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d
Cleared Sep 15, 2000
NICORE MODEL ESP -1
K980937 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 918d
Cleared Sep 13, 2000
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
K002544 · DQK
Oxford Instruments
Cardiovascular · 27d
Cleared Sep 13, 2000
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 23d
Cleared Sep 13, 2000
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992476 · MWS
Pilling Weck Surgical
Cardiovascular · 415d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416 · DQO
Medical Device Technologies, Inc.
Cardiovascular · 34d
Cleared Sep 11, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
K002722 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 11d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 94d
Cleared Sep 07, 2000
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
K000830 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 177d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 183d
Cleared Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
K001149 · DWJ
Augustine Medical, Inc.
Cardiovascular · 149d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · DTM
Terumo Medical Corp.
Cardiovascular · 65d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 51d
Cleared Sep 06, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
K002655 · DXN
Meditec Co., Ltd.
Cardiovascular · 12d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 197d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Aug 31, 2000
VASOTRAX
K001898 · DXN
Medwave, Inc.
Cardiovascular · 70d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · DRF
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 31, 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · KFM
Jostra Medizintechnik AG
Cardiovascular · 457d