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

KCT 2021-07-06

KARL STORZ Metal Sterilization Trays

Applicant Karl Storz Endoscopy America, Inc.

K-Number K203198

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DZE 2021-07-06

NUVO CF Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K203309

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MNR 2021-07-06

AcuPebble SA

Applicant Acurable Limited

K-Number K210480

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GEX 2021-07-06

DEKA Motus AZ

Applicant El.En Electronic Engineering Spa

K-Number K211821

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OLX 2021-07-02

RICOH MEG

Applicant Ricoh Company, Ltd.

K-Number K210199

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FXX 2021-07-02

Disposable Surgical Mask

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K-Number K202954

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MRX 2021-07-02

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

Applicant Hamilton Thorne, Inc.

K-Number K202241

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MUU 2021-07-02

SyntrFuge System

Applicant Syntr Health Technologies, Inc.

K-Number K203800

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LKM 2021-07-02

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

Applicant Beckman Coulter, Inc.

K-Number K210127

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PDJ 2021-07-02

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200256

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IRP 2021-07-02

LX9max

Applicant Daesung Maref Co., Ltd.

K-Number K203498

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EIH 2021-07-02

Estar-Z

Applicant Osstem Implant Co., Ltd.

K-Number K210097

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