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
12673–12696 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 20, 1990
TYPE 9040/NEO
K896699 · DRT
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 20, 1990
TYPE 9140/NEO
K896700 · DRT
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 20, 1990
INTRAVASCULAR IMAGING SYSTEMS
K900305 · LYK
Intertherapy, Inc.
Cardiovascular · 89d
Cleared Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · DTB
Pacesetter Systems
Cardiovascular · 73d
Cleared Apr 20, 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · DTD
Medtronic Vascular
Cardiovascular · 71d
Cleared Apr 20, 1990
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · DTR
3M Company
Cardiovascular · 70d
Cleared Apr 19, 1990
BALLOON THERMODILUTION CATHETERS
K894401 · DQO
Worldwide Medical
Cardiovascular · 304d
Cleared Apr 19, 1990
SERIES 3001 IABP
K900281 · DSP
Boston Scientific Corp
Cardiovascular · 87d
Cleared Apr 19, 1990
E-CLIP
K900982 · LDF
Joel Cohen & Esther R. Cohen
Cardiovascular · 48d
Cleared Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 44d
Cleared Apr 18, 1990
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
K896862 · DSI
Del Mar Avionics
Cardiovascular · 133d
Cleared Apr 10, 1990
ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
K895433 · DSP
Aries Medical, Inc.
Cardiovascular · 215d
Cleared Apr 10, 1990
SOLOSTICK (AMPLATZ DILATOR NEEDLE)
K896096 · DRE
Microvena Corp.
Cardiovascular · 172d
Cleared Apr 10, 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K896438 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 152d
Cleared Apr 10, 1990
PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER
K897075 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 111d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · DRT
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Apr 10, 1990
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · DWJ
Shiley, Inc.
Cardiovascular · 84d
Cleared Apr 10, 1990
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
K900753 · DWF
Shiley, Inc.
Cardiovascular · 53d
Cleared Apr 06, 1990
SONICATH(TM) 5 F
K895542 · DQO
Boston Scientific Corp
Cardiovascular · 205d
Cleared Apr 04, 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · DRT
Marquette Electronics, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
ELATEC HOLTER ANALYZER
K895806 · DSI
Ela Medical, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
CARDISUNY, 501BX
K900849 · LOS
Graham-Field, Inc.
Cardiovascular · 41d
Cleared Apr 04, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
K901032 · DPS
Accucore, Inc.
Cardiovascular · 29d
Cleared Apr 03, 1990
PREBYPASS FILTER, CAT. NO. FPB-5
K900672 · KRJ
American Omni Medical, Inc.
Cardiovascular · 49d