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
9673–9696 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 18, 1998
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION...
K982182 · DXC
Radi Medical Systems AB
Cardiovascular · 88d
Cleared Sep 17, 1998
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 20d
Cleared Sep 16, 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · DYB
Daig Corp.
Cardiovascular · 86d
Cleared Sep 15, 1998
OSCILLOMATE EMS NIBP MONITOR MODEL 9001
K982135 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 90d
Cleared Sep 11, 1998
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
K980578 · DYB
Innerdyne, Inc.
Cardiovascular · 206d
Cleared Sep 11, 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Sep 10, 1998
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120...
K980869 · DTB
Biotronik, Inc.
Cardiovascular · 188d
Cleared Sep 10, 1998
CAPIOX SX HARDSHELL RESEVOIR
K982223 · DTN
Terumo Medical Corp.
Cardiovascular · 78d
Cleared Sep 10, 1998
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 76d
Cleared Sep 09, 1998
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE...
K980429 · DSI
Hewlett-Packard Co.
Cardiovascular · 217d
Cleared Sep 08, 1998
CARDIOVIEW 3000 SOFTWARE
K974352 · LOS
Micromedical, Inc.
Cardiovascular · 293d
Cleared Sep 04, 1998
BIOSENSORS EMBOLECTOMY CATHETER
K973477 · DXE
Sunscope Intl., Inc.
Cardiovascular · 354d
Cleared Sep 04, 1998
HEARTPORT ENDOPULMONARY VENT CATHETER
K981009 · DWF
Heartport, Inc.
Cardiovascular · 170d
Cleared Sep 04, 1998
STOCKERT COMPACT SYSTEM
K982014 · DTQ
Stoeckert Instrumente
Cardiovascular · 88d
Cleared Sep 04, 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100...
K982025 · MKJ
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Sep 04, 1998
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
K982883 · DQY
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Sep 01, 1998
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762 · DTM
Pall Corp.
Cardiovascular · 186d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Aug 31, 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · DXE
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Aug 28, 1998
CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL...
K982740 · DYB
Cordis Webster, Inc.
Cardiovascular · 22d
Cleared Aug 27, 1998
CAOW HEMOSTASIS SYSTEM
K972689 · DXC
Anlam Corp.
Cardiovascular · 406d
Cleared Aug 26, 1998
EC6 PLETHYSMOGRAPH
K982707 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 23d
Cleared Aug 25, 1998
MICROVIT MT-100
K973735 · DSH
Schiller America, Inc.
Cardiovascular · 329d
Cleared Aug 25, 1998
MT-200
K973751 · DQK
Schiller America, Inc.
Cardiovascular · 328d