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
6577–6600 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 13, 2007
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
K070112 · DWJ
Medcool, Inc.
Cardiovascular · 183d
Cleared Jul 11, 2007
M2 MONITOR
K071725 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 16d
Cleared Jul 11, 2007
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM,...
K071227 · PDU
Spectranetics Corp.
Cardiovascular · 69d
Cleared Jul 10, 2007
HIGHPAK-12
K062331 · MPD
Ad Elektronik GmbH
Cardiovascular · 334d
Cleared Jul 06, 2007
MODIFICATION TO: STOCKERT S5 SYSTEM
K071318 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 57d
Cleared Jul 05, 2007
STIFFER COAXIAL MICRO-INTRODUCER KIT
K071574 · DYB
Enpath Medical, Inc.
Cardiovascular · 27d
Cleared Jul 05, 2007
ATRICURE BIPOLAR SYSTEM
K043579 · OCL
AtriCure, Inc.
Cardiovascular · 919d
Cleared Jul 03, 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE...
K071253 · DTM
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · MWI
Omron Healthcare, Inc.
Cardiovascular · 17d
Cleared Jul 02, 2007
Z6 STIMULATOR
K070743 · JOQ
St Cardio Technologies, LLC
Cardiovascular · 108d
Cleared Jun 29, 2007
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
K071234 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 57d
Cleared Jun 29, 2007
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
K071226 · PDU
Spectranetics Corp.
Cardiovascular · 57d
Cleared Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 74d
Cleared Jun 29, 2007
GORE BALLOON SHEATH
K070770 · MJN
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared Jun 29, 2007
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · MLO
Medick Healthcare , Ltd.
Cardiovascular · 235d
Cleared Jun 29, 2007
PALM ECG RECORDER, MODEL EP-201/202
K061123 · DPS
Parama-Tech Company., Ltd.
Cardiovascular · 431d
Cleared Jun 26, 2007
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700...
K071523 · DXN
Genexel-Sein, Inc.
Cardiovascular · 22d
Cleared Jun 26, 2007
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS
K070791 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 96d
Cleared Jun 22, 2007
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
K071025 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 72d
Cleared Jun 21, 2007
PRELUDE SHEATH INTRODUCER
K070159 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 155d
Cleared Jun 18, 2007
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010,...
K071125 · KRD
Aga Medical Corp.
Cardiovascular · 56d
Cleared Jun 18, 2007
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A...
K071020 · MHX
Ge Healthcare
Cardiovascular · 69d
Cleared Jun 18, 2007
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
K070288 · OCL
Medtronic Vascular
Cardiovascular · 139d
Cleared Jun 13, 2007
MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE...
K071426 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 21d