Search FDA 510(k) Database

6,976 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18385–18408 of 174,061
Cleared May 04, 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical...
K200871 · QEZ
Control Medical Technology
Cardiovascular · 33d
Cleared May 02, 2020
RIST Radial Access Catheter
K200417 · QJP
Rist Neurovascular, Inc.
Neurology · 72d
Cleared May 02, 2020
BOSS Balloon Guide Catheter
K200910 · QJP
Marblehead Medical
Neurology · 26d
Cleared May 01, 2020
FUJIFILM EP-6000 Video Processor
K192286 · FET
Fujifilm Corporation
Gastroenterology & Urology · 253d
Cleared May 01, 2020
PDT-FACE
K192295 · OLP
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 252d
Cleared May 01, 2020
Image Guidance System for Radiotherapy
K192405 · IYE
Jiangsu Rayer Medical Technology Co.,...
Radiology · 241d
Cleared May 01, 2020
Kitazato ET Catheters
K192540 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 228d
Cleared May 01, 2020
GUS831 Compressor Nebulizer
K192633 · CAF
Globalcare Medical Technology Co., Ltd.
Anesthesiology · 221d
Cleared May 01, 2020
Optimized Positioning System (OPS) Insight
K192656 · LLZ
Corin USA
Radiology · 219d
Cleared May 01, 2020
Stone Retrieval Balloon
K200173 · GCA
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 99d
Cleared May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal)...
K200279 · DHB
Phadia AB
Immunology · 87d
Cleared May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS...
K200453 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 67d
Cleared May 01, 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · NKG
Spineart
Orthopedic · 58d
Cleared May 01, 2020
O-Genesis Graft Delivery System
K200606 · FMF
Orthofix, Inc.
General & Plastic Surgery · 53d
Cleared May 01, 2020
Carnation Ambulatory Monitor
K200870 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared May 01, 2020
Azurion R2.1
K200917 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared May 01, 2020
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless...
K201004 · MQB
Iray Technology Taicang , Ltd.
Radiology · 15d
Cleared May 01, 2020
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound...
K201012 · IYN
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Apr 30, 2020
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · DXG
Pulsion Medical Systems SE
Cardiovascular · 265d
Cleared Apr 30, 2020
Biowy PICC Catheter S Kit
K192246 · LJS
Biowy Corporation
General Hospital · 255d
Cleared Apr 30, 2020
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g...
K192290 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 251d
Cleared Apr 30, 2020
Medical Non-Ablative Fractional Laser Systems
K192350 · ONG
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 245d
Cleared Apr 30, 2020
ArthrexVIP Web Portal
K193523 · LLZ
Arthrex, Inc.
Orthopedic · 133d
Cleared Apr 30, 2020
Turbett Instrument Pod
K200240 · FRG
Turbett Surgical, Inc.
General Hospital · 90d