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
13537–13560 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 24, 1988
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006 · DRY
Shiley, Inc.
Cardiovascular · 76d
Cleared May 20, 1988
BIOSOUND MMI ULTRASOUND
K871442 · JOP
Biosound, Inc.
Cardiovascular · 403d
Cleared May 19, 1988
EXTERNAL PACEMAKER WIRE DRESSING CHANGE
K881356 · LDF
Neal & Assoc., Inc.
Cardiovascular · 52d
Cleared May 18, 1988
INTRA-AORTIC BALLOON PUMP MODEL KAAT
K875036 · DSP
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K880167 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 120d
Cleared May 18, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
K881003 · DXN
Healthcheck Corp.
Cardiovascular · 70d
Cleared May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
K881279 · DTI
Baxter Healthcare Corp
Cardiovascular · 57d
Cleared May 18, 1988
MODEL 375 ECG
K881328 · DPS
Birtcher Corp.
Cardiovascular · 50d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K881732 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 26d
Cleared May 17, 1988
BATTERY PACKS FOR CARDIOVASCULAR UNITS
K881643 · MHX
Dowit Service Co., Inc.
Cardiovascular · 43d
Cleared May 16, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K875118 · JOM
Bloodflow Laboratory, Inc.
Cardiovascular · 153d
Cleared May 16, 1988
VASCU-CARE ANGIOSCOPE
K880927 · DQX
Vascu-Care, Inc.
Cardiovascular · 73d
Cleared May 16, 1988
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
K881197 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 56d
Cleared May 13, 1988
STAT-SAT
K874839 · DRY
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared May 13, 1988
RM-301 PATIENT MONITOR
K880498 · DRT
Ppg Industries, Inc.
Cardiovascular · 98d
Cleared May 13, 1988
VITEL III CM
K880533 · DXH
Equimed Corp.
Cardiovascular · 94d
Cleared May 13, 1988
AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30
K880615 · DXH
Cardiotechnics, Inc.
Cardiovascular · 87d
Cleared May 13, 1988
INJECTOR HANDLE WITH SYRINGE
K880987 · DXT
Applied Vascular Devices, Inc.
Cardiovascular · 66d
Cleared May 12, 1988
CARDIOBEEPER(R) III
K880300 · DXH
Survival Technology, Inc.
Cardiovascular · 108d
Cleared May 12, 1988
HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
K880780 · DRL
First Medical Devices Corp.
Cardiovascular · 76d
Cleared May 11, 1988
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
K874861 · DPT
Acuson Computed Sonography
Cardiovascular · 166d
Cleared May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · DTR
Shiley, Inc.
Cardiovascular · 83d
Cleared May 11, 1988
DATALOGGER CHART RECORDER
K880781 · DSF
Air-Shields, Inc.
Cardiovascular · 75d
Cleared May 10, 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K874917 · DXN
Oxford Medilog, Inc.
Cardiovascular · 159d