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

IRP 2018-12-27

Pulse 2.0, Pulse Pro 2.0

Applicant NormaTec Industries, LP

K-Number K183169

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IYN 2018-12-27

minisono

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K182845

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NXO 2018-12-26

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device

Applicant DiaSorin, Inc.

K-Number K182698

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HRS 2018-12-26

DePuy Synthes Trauma Orthopedic Nail Implants

Applicant DePuy Synthes

K-Number K182783

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LPH 2018-12-26

Delta TT Pro

Applicant Lima Corporate S.P.A.

K-Number K182099

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KOB 2018-12-26

One-Step Suprapubic Introducer

Applicant Cook Incorporated

K-Number K182709

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LZO 2018-12-26

Zimmer Biomet Select Ceramic Heads

Applicant Zimmer, Inc.

K-Number K181761

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QEM 2018-12-26

VO200 NeurOs Cerebral Oximetry System

Applicant Mespere Lifesciences, Inc.

K-Number K182242

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QSY 2018-12-24

QuikClot Radial

Applicant Z-Medica, LLC

K-Number K181641

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LKP 2018-12-24

EliA SmDP Immunoassay

Applicant Phadia AB

K-Number K183007

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NUC 2018-12-21

Creme de La Femme Feminine Lubricant

Applicant Cewal, Inc. Dba Premiere Enterprises

K-Number K180014

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KCT 2018-12-21

SterilContainer S System

Applicant Aesculap, Inc.

K-Number K182032

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