Search FDA 510(k) Database

7,018 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19057–19080 of 174,061
Cleared Feb 16, 2020
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
K193554 · HRS
Medartis AG
Orthopedic · 58d
Cleared Feb 14, 2020
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · GYC
Blackrock Microsystems
Neurology · 270d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 14, 2020
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for...
K191364 · JOZ
Fujimori Kogyo, Co., Ltd.
Hematology · 268d
Cleared Feb 14, 2020
The Graft Bone Substitute
K191737 · NPM
Purgo Biologics, Inc.
Dental · 231d
Cleared Feb 14, 2020
Orion LifeSpan MEG
K191785 · OLY
Compumedics Limited
Neurology · 226d
Cleared Feb 14, 2020
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal...
K192120 · BTR
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 192d
Cleared Feb 14, 2020
Maximus System
K192143 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 190d
Cleared Feb 14, 2020
CardIQ Flow
K192277 · KPS
GE Medical Systems SCS
Radiology · 176d
Cleared Feb 14, 2020
ASCEND Image Viewer
K192372 · LLZ
Ascend Hit
Radiology · 168d
Cleared Feb 14, 2020
CapsoCam Plus (SV-3) Capsule Endoscopy System
K192662 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 142d
Cleared Feb 14, 2020
Vitrea Software Package
K192923 · LLZ
Canon Medical Systems Corporation
Radiology · 121d
Cleared Feb 14, 2020
Real Intelligence Cori
K193120 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 94d
Cleared Feb 14, 2020
Affinity
K193152 · KPS
Hermes Medical Solutions AB
Radiology · 93d
Cleared Feb 14, 2020
Dunamis PunchTac Suture Anchors
K193245 · MBI
Dunamis, LLC
Orthopedic · 81d
Cleared Feb 14, 2020
Biograph Vision, Biograph mCT Family of PET/CTs
K193248 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d
Cleared Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502 · PGW
Stryker Ent
Ear, Nose, Throat · 58d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Feb 14, 2020
E-COM DR-2000 DR
K193644 · MQB
Livermoretech, Inc.
Radiology · 46d
Cleared Feb 14, 2020
EMBA Hourglass Peripheral Embolization Device (PED)
K200083 · KRD
Embolic Acceleration, LLC
Cardiovascular · 30d
Cleared Feb 13, 2020
Implacil Implant System
K183024 · DZE
Implacil DE Bortoli Material...
Dental · 469d
Cleared Feb 13, 2020
XenoSure Biologic Patch
K190882 · PSQ
Lemaitre Vascular
General & Plastic Surgery · 315d
Cleared Feb 13, 2020
ArtiSential Bipolar Fenestrated Forceps
K190909 · GEI
Livsmed, Inc.
General & Plastic Surgery · 311d