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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
13681–13704 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 18, 1988
KENSEY CATHETER
K880194 · LIT
Theratek, Inc.
Cardiovascular · 90d
Cleared Apr 11, 1988
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 76d
Cleared Apr 11, 1988
KING OF HEARTS
K880626 · DXH
Instromedix, Inc.
Cardiovascular · 55d
Cleared Apr 11, 1988
SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE
K881085 · DRX
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared Apr 01, 1988
GUIDE WIRE INTRODUCER
K873972 · DQX
Target Therapeutics
Cardiovascular · 185d
Cleared Apr 01, 1988
CIRCADIAN STRESS TEST II
K874641 · DPS
Circadian, Inc.
Cardiovascular · 140d
Cleared Apr 01, 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816 · DSP
Kontron Instruments, Inc.
Cardiovascular · 120d
Cleared Apr 01, 1988
COBE CML3
K880021 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 87d
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052 · DTJ
Baxter Healthcare Corp
Cardiovascular · 86d
Cleared Mar 31, 1988
MASCOT STETHOSCOPE PROBE
K874726 · DQD
Imex Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 31, 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · DSK
A&D Engineering, Inc.
Cardiovascular · 80d
Cleared Mar 31, 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
K875322 · KRK
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
K875323 · DQX
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 25, 1988
DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
K873410 · DXT
Blood Gas Supply Co.
Cardiovascular · 213d
Cleared Mar 25, 1988
MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
K875324 · DXT
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 25, 1988
MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
K875327 · DRE
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 22, 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126 · DTB
Intermedics, Inc.
Cardiovascular · 294d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · DQX
Cordis Corp.
Cardiovascular · 211d
Cleared Mar 22, 1988
BLOOD PRESSURE SLEEVE W/TUBING
K874233 · DXQ
Devcom, Inc.
Cardiovascular · 159d
Cleared Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 104d
Cleared Mar 22, 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · DWF
Dlp, Inc.
Cardiovascular · 82d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 71d
Cleared Mar 22, 1988
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.
K880103 · DWF
Research Medical, Inc.
Cardiovascular · 70d