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
8809–8832 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 22, 2001
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · DTD
Oscor, Inc.
Cardiovascular · 68d
Cleared May 18, 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · JOW
Britt Corp., Inc.
Cardiovascular · 158d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021,...
K010162 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 121d
Cleared May 18, 2001
VENA TECH VENA CAVA FILTER
K010485 · DTK
Bbraun
Cardiovascular · 87d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · DQX
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · DQO
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
K003707 · MWJ
Cardionet
Cardiovascular · 166d
Cleared May 16, 2001
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
K003732 · DXN
Braun GmbH
Cardiovascular · 163d
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F),...
K003880 · DQY
Concentric Medical, Inc.
Cardiovascular · 152d
Cleared May 16, 2001
ACTIVEECG
K010587 · DRT
Active Corp.
Cardiovascular · 78d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 15, 2001
GUIDANT RETRIEVER DEVICE
K001694 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 347d
Cleared May 14, 2001
SMARTFLOW, MODEL SFIP 2000
K003122 · DSK
Florence Medical , Ltd.
Cardiovascular · 221d
Cleared May 14, 2001
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
K004012 · DYF
Impra, Inc.
Cardiovascular · 138d
Cleared May 14, 2001
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001
K010436 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 90d
Cleared May 11, 2001
CARDIAC FUNCTION LABORATORY
K003020 · DQO
Cd Leycom BV
Cardiovascular · 226d
Cleared May 10, 2001
BRIDGE III RECEIVER
K010794 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 55d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120 · DSI
Mennen Medical , Ltd.
Cardiovascular · 396d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER...
K011098 · MXC
Medtronic Vascular
Cardiovascular · 23d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · DSP
Arrow Intl., Inc.
Cardiovascular · 282d
Cleared May 02, 2001
VASCULAR ASSIST
K002186 · DPW
Huntleigh Healthcare, Inc.
Cardiovascular · 286d