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
8569–8592 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · DQY
Abbott Vascular, Inc.
Cardiovascular · 28d
Cleared Jan 11, 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 25d
Cleared Jan 10, 2002
DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
K013478 · DXN
Pulse Metric, Inc.
Cardiovascular · 83d
Cleared Jan 10, 2002
INFINITY EXPLORER
K013515 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 80d
Cleared Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · DQK
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ
Dideco S.P.A.
Cardiovascular · 28d
Cleared Jan 04, 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · KRH
St. Jude Medical, Inc.
Cardiovascular · 28d
Cleared Jan 03, 2002
NEOLEAD
K011564 · DRX
Neotech Products, Inc.
Cardiovascular · 227d
Cleared Jan 03, 2002
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
K013311 · MHX
Micromedical Industries, Ltd.
Cardiovascular · 91d
Cleared Jan 03, 2002
NUMED MULLINS PTA CATHETER
K013601 · DQY
NuMED, Inc.
Cardiovascular · 64d
Cleared Dec 27, 2001
D902 PH.I.S.I.O OXYGENATOR
K013915 · DTZ
Dideco S.P.A.
Cardiovascular · 30d
Cleared Dec 21, 2001
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
K011832 · NMF
Vanguard Medical Concepts, Inc.
Cardiovascular · 192d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · DQY
Boston Scientific Corp
Cardiovascular · 186d
Cleared Dec 21, 2001
NORMATEC PCD
K013436 · JOW
Normatec, Inc.
Cardiovascular · 66d
Cleared Dec 20, 2001
GELBISH VASCULAR DILATOR
K012256 · DRE
Vascumetrix, LLC
Cardiovascular · 155d
Cleared Dec 18, 2001
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
K011907 · DWJ
Sims Level 1, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2001
DATACAPTOR
K013019 · MWI
Capsule Technologie
Cardiovascular · 102d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Radi Medical Systems AB
Cardiovascular · 19d
Cleared Dec 14, 2001
JOSTRA FLOWPROBE FP-32E
K013939 · DPT
Jostra AG
Cardiovascular · 15d
Cleared Dec 13, 2001
MODIFICATION TO THE GRIP
K010526 · LIX
Elcare Innovations, Inc.
Cardiovascular · 294d
Cleared Dec 13, 2001
CAIRD TECHNOLOGY HOLTER 2000
K012686 · DPS
Caird Technology
Cardiovascular · 121d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Dec 13, 2001
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
K013358 · DXN
Pulse Metric, Inc.
Cardiovascular · 64d