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
6385–6408 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 16, 2008
CHEETAH RELIANT, CHEETAH ACTIVE
K072662 · DSB
Cheetah Medical, Inc.
Cardiovascular · 117d
Cleared Jan 15, 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090 · DTK
C.R. Bard, Inc.
Cardiovascular · 75d
Cleared Jan 11, 2008
MODIFICATION TO: BPCARD, MODEL Z-7000-0700
K073630 · DXN
Qrs Diagnostic, LLC
Cardiovascular · 16d
Cleared Jan 11, 2008
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
K073462 · MHX
Ge Medical Systems Information...
Cardiovascular · 32d
Cleared Jan 11, 2008
MICROSHEATH XL CATHETERS
K073289 · DQY
Flowcardia, Inc.
Cardiovascular · 51d
Cleared Jan 11, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP...
K073198 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 59d
Cleared Jan 11, 2008
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
K073038 · DRG
Carematix, Inc.
Cardiovascular · 74d
Cleared Jan 11, 2008
HEARTEVENT, MODEL AT
K072385 · DXH
Diagnostic Devices Pty, Ltd.
Cardiovascular · 140d
Cleared Jan 11, 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · KRD
MicroVention, Inc.
Cardiovascular · 182d
Cleared Jan 10, 2008
PC-180 / PRINCE 180 EASY ECG MONITOR
K073152 · DSH
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 63d
Cleared Jan 09, 2008
VACCESS PTA BALLOON DILATATION CATHETER
K073472 · LIT
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Jan 09, 2008
CPS COURIER GUIDEWIRE
K073082 · DQX
Brivant, Ltd.
Cardiovascular · 69d
Cleared Jan 09, 2008
SIBEL SA VASCULAR CLAMP
K072834 · DXC
Surgical Instruments Belgium SA
Cardiovascular · 98d
Cleared Jan 09, 2008
ASAHI PTCA GUIDE WIRE
K070945 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 280d
Cleared Jan 04, 2008
VITALLINK3 MOBILE VITAL SIGNS SYSTEM
K073094 · MWI
Telemedic Systems, Ltd.
Cardiovascular · 64d
Cleared Jan 04, 2008
Y-GLIDE
K072745 · DTL
Thomas Medical Products, Inc.
Cardiovascular · 99d
Cleared Jan 04, 2008
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K070605 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 305d
Cleared Jan 03, 2008
INFINITY PICCO POD, MODEL MS16734
K073113 · DXG
Draeger Medical Systems, Inc.
Cardiovascular · 59d
Cleared Dec 28, 2007
ADVANCE 18LP PTA DILATATION CATHETER
K073378 · DQY
Cook, Inc.
Cardiovascular · 25d
Cleared Dec 28, 2007
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · DRA
Cryocath Technologies, Inc.
Cardiovascular · 324d
Cleared Dec 21, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
K072886 · DXT
Medrad, Inc.
Cardiovascular · 73d
Cleared Dec 20, 2007
VARICATH PERIPHERAL INFUSION CATHETER
K073400 · KRA
Veinrx, Inc.
Cardiovascular · 16d
Cleared Dec 20, 2007
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
K073398 · DXN
Microlife Corp.
Cardiovascular · 17d
Cleared Dec 20, 2007
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
K073397 · DXN
Microlife Corp.
Cardiovascular · 17d