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
9289–9312 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 28, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR...
K992273 · MHX
Hewlett-Packard GmbH
Cardiovascular · 205d
Cleared Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667 · DSY
Sulzermedica
Cardiovascular · 88d
Cleared Jan 27, 2000
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K993639 · LIT
Guidant Corp.
Cardiovascular · 91d
Cleared Jan 24, 2000
POWERHEART AECD
K993533 · MKJ
Cardiac Science, Inc.
Cardiovascular · 97d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER...
K994331 · MXC
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 19, 2000
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
K991545 · DXQ
Industrielle Entwicklung...
Cardiovascular · 261d
Cleared Jan 18, 2000
MULTIFUNCTION KEITO K5
K984083 · DXN
Bumedco Intl., Inc.
Cardiovascular · 428d
Cleared Jan 14, 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · MSX
Spacelabs Medical, Inc.
Cardiovascular · 151d
Cleared Jan 14, 2000
IBC FLOGUARD, MODEL 6050
K992785 · MJJ
International Biophysics Corp.
Cardiovascular · 148d
Cleared Jan 13, 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · DXC
Aesculap, Inc.
Cardiovascular · 209d
Cleared Jan 13, 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · JOW
Aircast, Inc.
Cardiovascular · 174d
Cleared Jan 13, 2000
PE 501 PC-ECG MONITOR
K992584 · MWJ
Nhe Corp.
Cardiovascular · 164d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · DSI
Datascope Corp.
Cardiovascular · 87d
Cleared Jan 13, 2000
AVIVA SYSTEM, MODEL SL1010
K993550 · DRG
American Telecare, Inc.
Cardiovascular · 85d
Cleared Jan 13, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208 · DTM
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · DQX
Cordis Corp.
Cardiovascular · 17d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · KRD
Cook, Inc.
Cardiovascular · 90d
Cleared Jan 11, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
K993460 · DXN
Rossmax International , Ltd.
Cardiovascular · 90d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
K993426 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
K993429 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 06, 2000
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K983866 · DSP
Belmont Instrument Corp.
Cardiovascular · 430d
Cleared Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · DRB
Endocardial Solutions, Inc.
Cardiovascular · 90d
Cleared Jan 04, 2000
TFX MEDICAL INTRODUCER KIT
K991647 · DYB
Tfx Medical Group
Cardiovascular · 236d
Cleared Jan 04, 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 64d