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
9961–9984 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 30, 1997
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970638 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 252d
Cleared Oct 28, 1997
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
K970264 · DYB
Cordis Webster, Inc.
Cardiovascular · 278d
Cleared Oct 28, 1997
CHASE TEMPERATURE PROBE
K971013 · DTN
Chase Medical, Inc.
Cardiovascular · 222d
Cleared Oct 23, 1997
EDEMA SYSTEM
K962783 · DSB
Bioanalogics, Inc.
Cardiovascular · 463d
Cleared Oct 23, 1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · DRF
C.R. Bard, Inc.
Cardiovascular · 202d
Cleared Oct 22, 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · MSX
Marquette Electronics, Inc.
Cardiovascular · 168d
Cleared Oct 22, 1997
MDP2000 MEDICAL DATA PROCESSOR
K972880 · MSX
Vidco, Inc.
Cardiovascular · 78d
Cleared Oct 21, 1997
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND...
K971436 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 186d
Cleared Oct 21, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · DPS
Alexander Mfg. Co.
Cardiovascular · 90d
Cleared Oct 21, 1997
VISTA BRITE TIP GUIDING CATHETERS
K972978 · DQY
Cordis Corp.
Cardiovascular · 71d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 16, 1997
HARMAC BALLOON ANGIOGRAPHIC CATHETER
K962829 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
HARMAC BALLOON WEDGE PRESSURE CATHETER
K963335 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
POWERHEART AECD
K970741 · MKJ
Cardiac Science, Inc.
Cardiovascular · 230d
Cleared Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · LDF
Harmac Medical Products, Inc.
Cardiovascular · 474d
Cleared Oct 14, 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
K972762 · DQX
Cardio Metrics, Inc.
Cardiovascular · 82d
Cleared Oct 10, 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112 · DQO
Medline Industries, Inc.
Cardiovascular · 294d
Cleared Oct 10, 1997
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
K972684 · DYB
Innerdyne, Inc.
Cardiovascular · 85d
Cleared Oct 09, 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
K971281 · DQX
Medcomp
Cardiovascular · 185d
Cleared Oct 08, 1997
GELBFISH ENDO-VAC SYSTEM
K970233 · MCW
Gary A. Gelbfish
Cardiovascular · 260d
Cleared Oct 08, 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 152d
Cleared Oct 08, 1997
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
K971877 · DTZ
Dideco S.P.A.
Cardiovascular · 140d