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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11329–11352 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 10, 1994
VALVULOTOME
K925283 · MGZ
Intramed Laboratories, Inc.
Cardiovascular · 478d
Cleared Feb 10, 1994
GUIDING CATHETER
K930476 · DQY
Boston Scientific Corp
Cardiovascular · 377d
Cleared Feb 09, 1994
CRITIKON CENTRAL STATIN MONITOR
K933404 · DPS
Critikon Company, LLC
Cardiovascular · 212d
Cleared Feb 09, 1994
JOBST ATHROMBIC PUMP - SYSTEM 2500
K934639 · JOW
Jobst Institute, Inc.
Cardiovascular · 133d
Cleared Feb 07, 1994
BATTERY PACK 1017LA
K931716 · DSI
Portable Power Systems, Inc.
Cardiovascular · 307d
Cleared Feb 07, 1994
MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA...
K933586 · DTZ
Medtronic Vascular
Cardiovascular · 196d
Cleared Feb 04, 1994
SARNS AIR DETECTION SYSTEM
K935977 · KRL
3M Health Care, Sarns
Cardiovascular · 53d
Cleared Feb 03, 1994
BATTERY PACK #1012NC
K931266 · LDD
Portable Power Systems, Inc.
Cardiovascular · 332d
Cleared Feb 01, 1994
QUEST HEART INSULATION PAD
K925049 · DWF
Quest Medical, Inc.
Cardiovascular · 483d
Cleared Feb 01, 1994
GC IV CORONARY GUIDING CATHETER
K932933 · DQY
Medtronics Interventional Vascular
Cardiovascular · 230d
Cleared Jan 28, 1994
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069 · LDF
J-Lloyd Medical, Inc.
Cardiovascular · 387d
Cleared Jan 27, 1994
SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING
K935501 · LIT
Scimed Peripheral Interventions
Cardiovascular · 72d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334 · DQX
Boston Scientific Corp
Cardiovascular · 202d
Cleared Jan 26, 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · DSY
Baxter Healthcare Corp
Cardiovascular · 184d
Cleared Jan 24, 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · DYG
Baxter Healthcare Corp
Cardiovascular · 112d
Cleared Jan 24, 1994
NAMTAI
K935872 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 59d
Cleared Jan 21, 1994
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
K934901 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 99d
Cleared Jan 18, 1994
LEADWIRE
K933603 · DSA
Sentry Medical Products, Inc.
Cardiovascular · 175d
Cleared Jan 18, 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 131d
Cleared Jan 18, 1994
ANGIOSCOPE
K934696 · LYK
Intramed Laboratories, Inc.
Cardiovascular · 110d
Cleared Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Jan 18, 1994
MEDSIM 300 PATIENT SIMULATOR
K935817 · DRT
Dynatech/Nevada, Inc.
Cardiovascular · 47d
Cleared Jan 14, 1994
RI-MED
K925297 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 450d
Cleared Jan 14, 1994
9750 ATHENA ETHERNET OPTION
K934887 · DXK
S & W Medico Teknik A/S
Cardiovascular · 94d