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

HSN 2023-01-27

Prophecy Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K-Number K222835

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ETN 2023-01-27

C2 Xplore

Applicant Inomed Medizintechnik GmbH

K-Number K223254

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HRS 2023-01-27

Tibia and Fibula System

Applicant Auxein Medical Private Limited

K-Number K213059

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MLM 2023-01-27

Tacrolimus Assay Kit

Applicant Shanghai Genext Medical Technology Co., Ltd.

K-Number K203833

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LON 2023-01-27

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin

Applicant bioMerieux, Inc.

K-Number K220803

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PZO 2023-01-27

Sim&Size

Applicant Sim&Cure

K-Number K222664

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PSZ 2023-01-27

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

Applicant Bd

K-Number K223016

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QFM 2023-01-27

QOCA image Smart CXR Image Processing System

Applicant Quanta Computer, Inc.

K-Number K221868

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LZA 2023-01-27

Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

Applicant Semperit Investments Asia Pte , Ltd.

K-Number K223903

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CGA 2023-01-27

GEM Premier ChemSTAT

Applicant Instrumentation Laboratory CO

K-Number K223090

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ISA 2023-01-27

Omnispec ED1000

Applicant Medispec, Ltd.

K-Number K210166

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GEX 2023-01-27

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories

Applicant Gyrus Acmi, Inc.

K-Number K221306

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