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
13585–13608 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Mar 22, 1988
ANGIOPLASTY BALLOON INFLATION DEVICE
K880158 · LIT
L.O.N. Research, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1988
STATFLO
K880180 · DWF
Imodex, Inc.
Cardiovascular · 69d