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
7129–7152 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 18, 2005
MEDITECH MODEL ABPM-04
K051149 · DXN
Meditech Kft.
Cardiovascular · 198d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K052899 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 34d
Cleared Nov 17, 2005
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
K052565 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 59d
Cleared Nov 16, 2005
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052603 · NLH
Alliance Medical Corp.
Cardiovascular · 56d
Cleared Nov 16, 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · NLH
Alliance Medical Corp.
Cardiovascular · 75d
Cleared Nov 16, 2005
INFINITY ALPHA
K051658 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Nov 10, 2005
JOSTRA HLM TUBING SET
K053025 · DWE
Maquet Cardiopulmonary, AG
Cardiovascular · 14d
Cleared Nov 10, 2005
CG FUTURE ANNULOPLASTY BAND
K052860 · KRH
Medtronic Heart Valves
Cardiovascular · 30d
Cleared Nov 10, 2005
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · QEZ
Possis Medical, Inc.
Cardiovascular · 84d
Cleared Nov 10, 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · DQD
Inovise Medical, Inc.
Cardiovascular · 161d
Cleared Nov 07, 2005
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · NFA
Boston Scientific Corp
Cardiovascular · 77d
Cleared Nov 04, 2005
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K052791 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 32d
Cleared Nov 04, 2005
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312 · DSY
Veryan Medical Limited
Cardiovascular · 169d
Cleared Nov 04, 2005
INVOS SYSTEM
K051274 · MUD
Somanetics Corp.
Cardiovascular · 171d
Cleared Nov 02, 2005
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50,...
K052801 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 30d
Cleared Nov 02, 2005
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
K051799 · DXT
Coeur, Inc.
Cardiovascular · 120d
Cleared Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
K051561 · DQO
Asahi Intecc Co., Ltd.
Cardiovascular · 142d
Cleared Nov 01, 2005
CARDIOSERVER
K052883 · DQK
Datrix
Cardiovascular · 19d
Cleared Nov 01, 2005
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
K052756 · MHX
Ge Healthcare
Cardiovascular · 32d
Cleared Oct 31, 2005
VP SHEATH
K051580 · DQY
Flowcardia, Inc.
Cardiovascular · 138d
Cleared Oct 28, 2005
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K052757 · LIT
Biotronik AG
Cardiovascular · 28d
Cleared Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
K050233 · DXN
Omron Healthcare, Inc.
Cardiovascular · 269d
Not Cleared Oct 28, 2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
DEN050006 · NQH
Cardiomems, Inc.
Cardiovascular · 80d
Cleared Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783 · DQX
Boston Scientific Corp
Cardiovascular · 24d