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

DZE 2022-07-08

Adin Short Implants

Applicant Adin Dental Implants Systems , Ltd.

K-Number K212775

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ELE 2022-07-08

KLS Martin IPS Preprosthetic

Applicant KLS-Martin L.P.

K-Number K210228

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FMK 2022-07-08

DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets

Applicant Htl-Strefa S.A

K-Number K220643

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JCT 2022-07-08

Through the Scope Tracheal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K220424

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HRS 2022-07-08

Stryker VariAx 2 MIS Calcaneus

Applicant Stryker GmbH

K-Number K221346

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JPA 2022-07-08

ROTEM sigma Thromboelastometry System

Applicant Tem Innovations GmbH

K-Number K201440

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PIG 2022-07-08

VIDAS NEPHROCHECK

Applicant Biomérieux SA

K-Number K210793

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LZA 2022-07-08

Powder Free Nitrile Examination Gloves (Blue)

Applicant Kgm Gloves Sdn. Bhd.

K-Number K220284

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LZA 2022-07-08

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

Applicant American Nitrile Operations, LLC

K-Number K220825

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QDQ 2022-07-08

ProstatID

Applicant Scanmed, LLC

K-Number K212783

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NUC 2022-07-07

Wet Essential95 Personal Lubricant

Applicant Trigg Laboratories, Inc.

K-Number K220534

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GEI 2022-07-07

AgeJet

Applicant Triworks Group Srl

K-Number K212472

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