Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HCI 2018-04-17

Aesculap Slim Clip Applier

Applicant Aesculap, Inc.

K-Number K180914

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FMI 2018-04-17

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

Applicant Teleflex Medical

K-Number K180588

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DXC 2018-04-17

PreludeSYNC DISTAL Radial Compression System

Applicant Merit Medical Systems, Inc.

K-Number K180723

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GEX 2018-04-17

Diode laser hair removal device

Applicant Zhengzhou PZ Laser Slim Technology Co., Ltd.

K-Number K180353

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FDF 2018-04-17

DiLumen C2; DiLumen Tool Mount

Applicant Lumendi, LLC

K-Number K173317

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GWQ 2018-04-17

WR19 System

Applicant Zeto, Inc.

K-Number K172735

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GEI 2018-04-17

THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Applicant Olympus Medical Systems Corp.

K-Number K172610

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MAX 2018-04-17

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

Applicant Innovasis, Inc.

K-Number K180078

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KNS 2018-04-17

Fusion OMNI Sphincterotome

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K172288

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NKB 2018-04-17

FOCUS Pedicle Screw System

Applicant Nvision Biomedical Technologies, LLC

K-Number K180458

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KPS 2018-04-17

NM/CT 850, NM/CT 860

Applicant GE Healthcare

K-Number K173816

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MCW 2018-04-17

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K180416

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