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

QMV 2024-12-05

BIOFIRE FILMARRAY Tropical Fever Panel

Applicant Biofire Diagnostics, LLC (Biomerieux)

K-Number K243463

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JWY 2024-12-05

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

Applicant Thermo Fisher Scientific

K-Number K242653

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MPA 2024-12-04

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

Applicant Alcon Laboratories, Inc.

K-Number K242184

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MUJ 2024-12-04

XBeam (v2)

Applicant Xstrahl, Ltd.

K-Number K240671

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EHD 2024-12-04

Rextar Pro

Applicant Raypia Co., Ltd.

K-Number K242185

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JWH 2024-12-04

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K242831

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MRW 2024-12-04

Ion 3D

Applicant SurGenTec, LLC

K-Number K243265

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HWC 2024-12-04

Locking Screw,CoCrMo

Applicant Double Medical Technology, Inc.

K-Number K242348

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CGX 2024-12-04

Atellica® CH Creatinine_3 (Crea3)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K242685

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QRA 2024-12-04

RelieVRx

Applicant Appliedvr

K-Number K243417

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NHA 2024-12-04

Neodent Implant System

Applicant Jjgc Indústria E Comércia DE Materiais Dentários S.A.

K-Number K242686

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JOJ 2024-12-04

Chemical Indicator for enspire CLCSPS (LCC015)

Applicant STERIS Corporation

K-Number K243475

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