Search FDA 510(k) Database

7,013 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18985–19008 of 174,061
Cleared Feb 26, 2020
ARK Fentanyl II Assay
K200197 · DJG
ARK Diagnostics, Inc.
Toxicology · 30d
Cleared Feb 25, 2020
Allcem Veneer APS
K191389 · EBF
Dentscare Ltda
Dental · 277d
Cleared Feb 25, 2020
Heater-Cooler System 3T
K191402 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 277d
Cleared Feb 25, 2020
SonicEye Dual-Array Ultrasound System
K192253 · IYO
Sonivate Medical, Inc.
Radiology · 189d
Cleared Feb 25, 2020
PneumoLiner
K192898 · PMU
Advanced Surgical Concepts
Obstetrics & Gynecology · 137d
Cleared Feb 25, 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 78d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Shanghai United Imaging Healthcare...
Radiology · 53d
Cleared Feb 25, 2020
Ez3D-i /E3
K200178 · LLZ
Ewoosoft Co., Ltd.
Radiology · 32d
Cleared Feb 25, 2020
Surgical laser fibers
K200234 · GEX
Quanta System Spa
General & Plastic Surgery · 26d
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · PMT
Ortho-Clinical Diagnostics
Microbiology · 26d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
K191474 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 265d
Cleared Feb 24, 2020
Pylant Monitor
K191858 · BSK
Kal-Med, LLC
Anesthesiology · 228d
Cleared Feb 24, 2020
Aquadex FlexFlow System 2.0
K192756 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 147d
Cleared Feb 24, 2020
DELTA XTEND(TM) Reverse Shoulder System
K192855 · PHX
Depuy(Ireland)
Orthopedic · 143d
Cleared Feb 24, 2020
Alliance Augmented Glenoid
K193180 · KWS
Zimmer, Inc.
Orthopedic · 98d
Cleared Feb 24, 2020
NEXXT MATRIXX System
K193412 · PLR
Nexxt Spine, LLC
Orthopedic · 77d
Cleared Feb 24, 2020
Titanium Interference Screws
K193451 · HWC
Biomet, Inc.
Orthopedic · 73d
Cleared Feb 24, 2020
3D Predict
K200214 · NXC
3D Smile USA, Inc.
Dental · 27d
Cleared Feb 23, 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · HSB
Stryker Trauma GmbH
Orthopedic · 86d
Cleared Feb 21, 2020
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia...
K190363 · MAX
Omnia Medical, LLC
Orthopedic · 371d
Cleared Feb 21, 2020
AR_N SLA Type Implant System
K190641 · DZE
Biotem Co., Ltd.
Dental · 345d
Cleared Feb 21, 2020
Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL...
K191030 · PCA
Life Technologies Corporation
Toxicology · 309d
Cleared Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
K191313 · QJY
DEKA Research & Development
General Hospital · 282d
Cleared Feb 21, 2020
Novalung System
K191407 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 269d