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
6001–6024 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 11, 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA,...
K083828 · MXC
Transoma
Cardiovascular · 50d
Cleared Feb 10, 2009
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
K081560 · DWF
Vascutek, Ltd.
Cardiovascular · 252d
Cleared Feb 06, 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040 · DQO
Terumo Medical Corp.
Cardiovascular · 31d
Cleared Feb 06, 2009
HI-TORQUE VERSACORE GUIDE WIRE
K083706 · DQX
Abbott Vascular
Cardiovascular · 53d
Cleared Feb 06, 2009
6F TAIGA GUIDING CATHETER
K083422 · DQY
Medtronic Vascular
Cardiovascular · 79d
Cleared Feb 06, 2009
CRYOVALVE SG PULMONARY VALVE AND CONDUIT
K083106 · OHA
Cryolife, Inc.
Cardiovascular · 109d
Cleared Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · DQX
Medtronic Vascular
Cardiovascular · 130d
Cleared Feb 06, 2009
BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
K080987 · DQY
Bridgepoint Medical
Cardiovascular · 305d
Cleared Feb 04, 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 70d
Cleared Feb 04, 2009
GORE FLOW REVERSAL SYSTEM
K083300 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 86d
Cleared Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082 · DTN
Gish Biomedical, Inc.
Cardiovascular · 196d
Cleared Feb 04, 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · DTN
Gish Biomedical, Inc.
Cardiovascular · 211d
Cleared Feb 03, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
K083287 · DSI
Corventis, Inc.
Cardiovascular · 88d
Cleared Feb 03, 2009
CROSSOVER
K083269 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 90d
Cleared Feb 03, 2009
ASAHI CORSAIR MICROCATHETER
K083127 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 105d
Cleared Feb 03, 2009
BLAZER DX-20 DIAGNOSTIC CATHETER
K081576 · DRF
Boston Scientific Corp
Cardiovascular · 243d
Cleared Feb 02, 2009
BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND...
K090027 · DXN
Zen Strong Medical Technology Co., Ltd.
Cardiovascular · 28d
Cleared Feb 02, 2009
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
K083313 · DQY
Avinger, Inc.
Cardiovascular · 84d
Cleared Feb 02, 2009
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
K080708 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 327d
Cleared Jan 29, 2009
ASAHI SUOH PTCA GUIDE WIRE
K083904 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
K083319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
K083318 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
K083317 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
K083248 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d