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
5113–5136 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 08, 2011
PACEART OPTIMA SYSTEM SOFTWARE
K110693 · KRE
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jun 08, 2011
ERKA. PERFECT-ANEROID
K103637 · DXQ
Erka Kallmeyer Medizintechnik GmbH
Cardiovascular · 177d
Cleared Jun 03, 2011
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645 · DSB
Sonosite,Inc.
Cardiovascular · 91d
Cleared Jun 03, 2011
CARDIO XP
K102767 · DPS
Bionet Co., Ltd.
Cardiovascular · 252d
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252 · DQY
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 02, 2011
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM...
K110617 · LOX
Abbott Vascular
Cardiovascular · 91d
Cleared Jun 02, 2011
OMNI II PATIENT MONITOR
K103737 · MWI
Infinium Medical
Cardiovascular · 162d
Cleared Jun 01, 2011
JETSTREAM G3 (R) SF 1.6 SYSTEM
K111229 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 01, 2011
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · MWI
Welch Allyn, Inc.
Cardiovascular · 98d
Cleared May 31, 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · LIT
Boston Scientific Corporation
Cardiovascular · 21d
Cleared May 31, 2011
M4 MONITOR
K110957 · DRY
Spectrum Medical, Llp
Cardiovascular · 56d
Cleared May 27, 2011
TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
K101681 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 346d
Cleared May 26, 2011
AFX INTRODUCER SYSTEM
K110090 · DYB
Endologix, Inc.
Cardiovascular · 134d
Cleared May 25, 2011
MUSE CARDIOLOGY INFORMATION SYSTEM
K110132 · DQK
Ge Medical Systems Information...
Cardiovascular · 127d
Cleared May 24, 2011
LIFEBRIDGE
K111384 · KFM
Lifebridge Medizintechnik AG
Cardiovascular · 7d
Cleared May 24, 2011
ANGIOJET SOLENT OMNI THROMBECTOMY SET
K111182 · QEZ
Medrad, Inc.
Cardiovascular · 27d
Cleared May 24, 2011
ARSTASIS DILATOR ADAPTER
K103421 · DRE
Arstasis, Inc.
Cardiovascular · 183d
Cleared May 23, 2011
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
K111154 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared May 23, 2011
GORE EMBOLIC FILTER
K103500 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 175d
Cleared May 20, 2011
HYDROFIX VASO SHIELD
K111137 · OMR
Mimedx Group, Inc.
Cardiovascular · 28d
Cleared May 20, 2011
SURESIGNS VS2 VITAL SIGNS MONITOR
K111114 · DXN
Philips Medical Systems
Cardiovascular · 29d
Cleared May 20, 2011
WITHINGS BLOOD PRESSURE MONITOR
K110872 · DXN
Withings
Cardiovascular · 52d
Cleared May 20, 2011
SURESIGNS VSI VITAL SIGNS MONITOR
K110803 · DXN
Philips Medical Systems
Cardiovascular · 58d
Cleared May 20, 2011
VITALSENS, AINGEAL, V-POD
K110015 · MHX
Intelesens Limited
Cardiovascular · 137d