FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
17065–17088 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 14, 1980
SMEC BALLOON CANNULA
K790755 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared May 14, 1980
PLASTIC TUBING ADAPTERS 5-IN-1-
K800880 · DTL
Harvard Laboratories
Cardiovascular · 27d
Cleared May 14, 1980
ACCUDYNAMIC
K801048 · DRS
Sorensen Research
Cardiovascular · 9d
Cleared May 14, 1980
DISPOSABLE PATIENT CABLE MODEL 5807
K801064 · DSA
Daig Corp.
Cardiovascular · 8d
Cleared May 02, 1980
PULSE GENERATORS MODELS 657 & 677
K800387 · DXY
Siemens Elema AB
Cardiovascular · 70d
Cleared Apr 29, 1980
EXTENSION LINE
K800622 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 42d
Cleared Apr 29, 1980
DIGITAL ELECTRONIC B.P. MONITOR 2155
K800778 · DXN
Sears, Roebuck & Co.
Cardiovascular · 21d
Cleared Apr 29, 1980
QUICK FILL
K800823 · DXT
Medrad, Inc.
Cardiovascular · 15d
Cleared Apr 24, 1980
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.
K800147 · KRH
Usifroid
Cardiovascular · 93d
Cleared Apr 24, 1980
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
K800618 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
THERMODILUTION CATHETER INTRO. KIT
K800619 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
PERCUTANEOUS CATHETER INTRODUCER ADAPTER
K800621 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
ECHO-COMP
K800766 · DQK
Digisonics, Inc.
Cardiovascular · 17d
Cleared Apr 24, 1980
MOD. MCI 17 MANUAL CUFF INFLATOR
K800767 · DXQ
Medasonics, Inc.
Cardiovascular · 17d
Cleared Apr 24, 1980
MEDI-THERM
K800812 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 13d
Cleared Apr 24, 1980
KMA FLOW DIRECTED THERMODILUTION CATHETE
K800836 · KRB
Kma, Inc.
Cardiovascular · 9d
Cleared Apr 24, 1980
SERIES 602 CKGTM RECORDER
K800851 · DSF
Cardio Kinetics, Inc.
Cardiovascular · 9d
Cleared Apr 24, 1980
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895 · DXY
Intermedics, Inc.
Cardiovascular · 3d
Cleared Apr 21, 1980
EPR-200 PROGRAMMER MODEL 010
K800376 · KRG
Biotronik Sales, Inc.
Cardiovascular · 60d
Cleared Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · LDF
C.R. Bard, Inc.
Cardiovascular · 65d
Cleared Apr 16, 1980
NOMOS-01 PULSE GENERATOR
K800375 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Apr 16, 1980
SURGERY DISPLAY SYSTEM
K800488 · DRQ
Kent Barker & Assoc.
Cardiovascular · 43d
Cleared Apr 16, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644 · DXY
Intermedics, Inc.
Cardiovascular · 23d