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

LZO 2020-02-28

Zimmer M/L Taper Hip Prosthesis

Applicant Zimmer, Inc.

K-Number K192660

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IYE 2020-02-28

Alta Multipurpose Device

Applicant Qfix

K-Number K193243

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MUH 2020-02-28

R-Sensor, R-Sensor

Applicant Remedi Co., Ltd.

K-Number K200284

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OVE 2020-02-28

Atlas Spine Expandable Cervical Standalone Interbody System

Applicant Atlas Spine, Inc.

K-Number K192570

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JAQ 2020-02-28

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor

Applicant Mick Radio-Nuclear Instruments, Inc.

K-Number K200221

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DWJ 2020-02-28

Arctic Sun Stat Temperature Management System

Applicant Medivance, Inc.

K-Number K200225

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QKB 2020-02-28

AccuContour

Applicant Xiamen Manteia Technology , Ltd.

K-Number K191928

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NKB 2020-02-28

Daytona® Small Stature Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K200381

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DTZ 2020-02-28

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

Applicant Chalice Medical , Ltd.

K-Number K191246

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JDR 2020-02-28

Superelastic Staple

Applicant Neosteo

K-Number K192447

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LLZ 2020-02-28

icobrain-ctp

Applicant Icometrix NV

K-Number K192962

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JPI 2020-02-28

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K183680

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