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
5281–5304 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 07, 2011
DISPOSABLE BLOOD PRESSURE CUFF
K102823 · DXQ
Wuxi Medical Instrument Factory
Cardiovascular · 100d
Cleared Jan 06, 2011
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
K103168 · DRY
Sorin Group Deutschland GmbH
Cardiovascular · 71d
Cleared Jan 06, 2011
KENZ CARDY302 MAX
K101024 · MWJ
Suzuken Co., Ltd.
Cardiovascular · 268d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · MCW
Ev3, Inc.
Cardiovascular · 26d
Cleared Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534 · DQY
Trireme Medical, Inc.
Cardiovascular · 35d
Cleared Jan 04, 2011
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
K102974 · MSX
Philips Medical Systems
Cardiovascular · 90d
Cleared Dec 30, 2010
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION...
K103153 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 77d
Cleared Dec 30, 2010
CANTATA MICROCATHETER
K101450 · KRA
Cook, Inc.
Cardiovascular · 220d
Cleared Dec 27, 2010
LIFEBRIDGE
K103357 · KFM
Lifebridge Medizintechnik AG
Cardiovascular · 41d
Cleared Dec 23, 2010
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS...
K094030 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 358d
Cleared Dec 22, 2010
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 22, 2010
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 33d
Cleared Dec 22, 2010
LIFEPAK 12
K102972 · MKJ
Physio-Control, Inc.
Cardiovascular · 77d
Cleared Dec 22, 2010
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
K101189 · DRS
Reavillmed
Cardiovascular · 238d
Cleared Dec 21, 2010
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
K101982 · DTA
St Jude Medical, Crmd
Cardiovascular · 160d
Cleared Dec 17, 2010
UNITY NETWORK ID
K103432 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 17, 2010
REGIONAL OXIMETER
K102715 · MUD
Nonin Medical, Inc.
Cardiovascular · 88d
Cleared Dec 17, 2010
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
K102106 · DRG
Nihon Kohden Corp.
Cardiovascular · 143d
Cleared Dec 16, 2010
AVITA WRIST TYPE BLOOD PRESSURE MONITOR
K102624 · DXN
Avita Corporation
Cardiovascular · 94d
Cleared Dec 16, 2010
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL...
K101659 · DQY
Vascular Solutions, Inc.
Cardiovascular · 188d
Cleared Dec 16, 2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · DTM
Medtronic, Inc.
Cardiovascular · 286d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Dec 10, 2010
VASCUCOMP
K103247 · JOW
Thermotek, Inc.
Cardiovascular · 37d
Cleared Dec 10, 2010
WILLOW/ELM PTA BALLOON DILATATION CATHETER
K102645 · LIT
Creagh Medical, Ltd.
Cardiovascular · 88d