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

LZC 2017-07-24

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

Applicant Careplus (M) Sdn Bhd

K-Number K162858

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LPH 2017-07-24

Klassic HD® Hip System

Applicant Total Joint Othopedics, Inc.

K-Number K171962

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IZI 2017-07-24

YELLOW 560 Fluorescence Module

Applicant Carl Zeiss Meditec, AG

K-Number K162991

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NHA 2017-07-24

Custom Bars

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K162633

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KTT 2017-07-24

DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates

Applicant Hnm Total Recon, LLC

K-Number K163486

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IMD 2017-07-24

Infant Transport Mattress Warmer with Disc

Applicant Rapid Aid Corp.

K-Number K163295

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NKB 2017-07-24

True Spinal Fixation System

Applicant Innovative Surgical Designs, Inc.

K-Number K171559

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JEY 2017-07-24

MP LeFort I Plates

Applicant Stryker

K-Number K171364

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MAX 2017-07-24

Rampart L Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K171724

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PEX 2017-07-22

VITEK MS

Applicant bioMerieux, Inc.

K-Number K162950

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OWB 2017-07-21

Ultimax-i, DREX-UI80 V1.60

Applicant Toshibamedical Systems Corporation

K-Number K170832

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LNH 2017-07-21

Vantage Elan 1.5T, V4.0

Applicant Toshibamedical Systems Corporation

K-Number K171597

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