Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MEH 2017-08-24

Entrada hip stem

Applicant Ortho Development Corporation

K-Number K171249

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KDI 2017-08-24

NxStage System One

Applicant Nxstage Medical, Inc.

K-Number K171331

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MBI 2017-08-24

Stryker Self-Punching ICONIX

Applicant Stryker

K-Number K171465

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HRS 2017-08-23

EVOS Small Fragment Plating System

Applicant Smith & Nephew, Inc.

K-Number K172262

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DRX 2017-08-23

Physiotrace

Applicant Nimbleheart, Inc.

K-Number K171244

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OHS 2017-08-23

LG BEAUTY LED MASK

Applicant Lg Electronics

K-Number K170984

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KWQ 2017-08-23

Ozark(tm) Cervical Plate System

Applicant K2m, Inc.

K-Number K172104

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FBK 2017-08-23

Endoscopic Injection Needle

Applicant Carbon Medical Technologies, Inc.

K-Number K172227

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MHX 2017-08-23

Passport Series Patient Monitors(Passport 12m, Passport 17m)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K170876

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NDN 2017-08-23

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

Applicant G-21 S.R.L.

K-Number K172214

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FRO 2017-08-22

SilverSeal

Applicant Alliqua Biomedical, Inc.

K-Number K171041

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FRC 2017-08-22

VERIFY Assert VH2O2 Self-Contained Biological Indicator

Applicant STERIS Corporation

K-Number K171504

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