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
9097–9120 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 01, 2000
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
K001182 · DXN
Microlife Corp.
Cardiovascular · 112d
Cleared Jul 28, 2000
DATA MASTER PERFUSION MONITORING SYSTEM
K001388 · DRY
Dideco
Cardiovascular · 87d
Cleared Jul 27, 2000
CARDIOVISE ECG INTERPRETATIVE SOFTWARE
K001349 · MWJ
Inovise Medical, Inc.
Cardiovascular · 90d
Cleared Jul 26, 2000
RESPIEVENTS, VERSION 4.2
K001369 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 86d
Cleared Jul 25, 2000
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
K002115 · DXN
A&D Engineering, Inc.
Cardiovascular · 12d
Cleared Jul 21, 2000
ARIA
K001317 · MWJ
Del Mar Medical Systems, LLC
Cardiovascular · 86d
Cleared Jul 21, 2000
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · DSA
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Jul 21, 2000
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K002046 · DXN
Vsm Technology, Inc.
Cardiovascular · 16d
Cleared Jul 21, 2000
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510
K994141 · MJN
Medtronic Ave, Inc.
Cardiovascular · 226d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · LIT
Cook, Inc.
Cardiovascular · 107d
Cleared Jul 20, 2000
DR180-II
K001288 · MWJ
North East Monitoring, Inc.
Cardiovascular · 87d
Cleared Jul 20, 2000
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
K001306 · DQD
Andromed, Inc.
Cardiovascular · 86d
Cleared Jul 20, 2000
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER...
K001966 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2000
BOOKER BOX, MODEL PAD 5010
K993205 · LDD
Tz Medical, Inc.
Cardiovascular · 300d
Cleared Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359 · DSI
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Jul 17, 2000
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
K001268 · MHX
General Electric Medical Systems...
Cardiovascular · 88d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · MSX
Datex-Ohmeda, Inc.
Cardiovascular · 136d
Cleared Jul 13, 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · MWI
Welch Allyn, Inc.
Cardiovascular · 85d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · DXF
NuMED, Inc.
Cardiovascular · 27d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248 · MJN
Aga Medical Corp.
Cardiovascular · 288d
Cleared Jul 07, 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · DTK
Cordis Corp.
Cardiovascular · 179d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · DQX
Nipro Medical Corp.
Cardiovascular · 79d
Cleared Jul 07, 2000
CARDEON ASCENDING BALLOON CANNULA (ABC)
K001371 · DWF
Cardeon Corp.
Cardiovascular · 67d