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
6265–6288 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 30, 2008
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
K080763 · DWJ
Talley Medical
Cardiovascular · 73d
Cleared May 30, 2008
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
K063723 · KFM
Abiomed, Inc.
Cardiovascular · 532d
Cleared May 29, 2008
GENESIS ECP
K081359 · DRN
Scottcare Corporation
Cardiovascular · 14d
Cleared May 29, 2008
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
K081257 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 27d
Cleared May 28, 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
K081220 · PNO
Angioscore, Inc.
Cardiovascular · 28d
Cleared May 28, 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · DYB
Terumo Medical Corp.
Cardiovascular · 44d
Cleared May 28, 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE...
K080551 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 90d
Cleared May 28, 2008
NRG TRANSSEPTAL NEEDLE
K073326 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 183d
Cleared May 21, 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · DYB
Terumo Medical Corp.
Cardiovascular · 37d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889 · DSI
Ge Healthcare
Cardiovascular · 315d
Cleared May 16, 2008
AMPLATZER TORQVUE EXCHANGE SYSTEM
K080994 · DQY
Aga Medical Corp.
Cardiovascular · 39d
Cleared May 14, 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 1d
Cleared May 14, 2008
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · MUD
Somanetics Corp.
Cardiovascular · 57d
Cleared May 14, 2008
HEARTRAK AF
K071130 · DXH
Universal Medical, Inc.
Cardiovascular · 387d
Cleared May 13, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
K080337 · DXN
Microlife Corp.
Cardiovascular · 95d
Cleared May 12, 2008
REVOLUTION 45MHZ IVUS IMAGING CATHETER
K080891 · OBJ
Volcano Corporation
Cardiovascular · 42d
Cleared May 09, 2008
PAGEWRITER CARDIOGRAPH
K080999 · DPS
Philips Medical Systems
Cardiovascular · 31d
Cleared May 09, 2008
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
K080177 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 106d
Cleared May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared May 07, 2008
BIO-CONSOLE 560
K080824 · DWA
Medtronic Perfusion Systems
Cardiovascular · 44d
Cleared May 07, 2008
OPTISTAR ELITE INJECTION SYSTEM
K073592 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 139d
Cleared May 05, 2008
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
K080605 · DSA
Curbell Electronics, Inc.
Cardiovascular · 62d
Cleared May 05, 2008
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL...
K080509 · OCL
Medtronic, Inc.
Cardiovascular · 70d
Cleared May 02, 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S)...
K072696 · DXT
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 221d