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

EIH 2021-08-26

Amber Mill Q Series & Amber Mill Direct Series

Applicant Hass Corp.

K-Number K202952

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GEI 2021-08-25

CellFX System

Applicant Pulse Biosciences, Inc.

K-Number K211444

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NGX 2021-08-25

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

Applicant Fit-Pro , Ltd.

K-Number K202148

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PHX 2021-08-25

Lateralized and Augmented Baseplates

Applicant Fx Shoulder USA, Inc.

K-Number K210790

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KRA 2021-08-25

PROWLER SELECT PLUS; PROWLER EX

Applicant Medos International SARL

K-Number K210838

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JWH 2021-08-25

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

Applicant Depuy Ireland UC

K-Number K211609

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GEX 2021-08-25

SCAR 3

Applicant El.En Electronic Engineering Spa

K-Number K211362

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MQB 2021-08-25

RFA-1717DIG, RFA-1717DIC

Applicant Astel, Inc.

K-Number K212051

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BTT 2021-08-25

HVT 2.0

Applicant Vapotherm, Inc.

K-Number K203357

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OLO 2021-08-25

ExcelsiusHub

Applicant Globus Medical, Inc.

K-Number K211616

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PKL 2021-08-25

Instinct Plus Endoscopic Clipping Device

Applicant Wilson-Cook Medical, Inc.

K-Number K212323

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IZL 2021-08-25

Diagnostic X-ray System/PLX5200A

Applicant Nanjing Perlove Medical Equipment Co., Ltd.

K-Number K212134

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