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

GEX 2022-04-20

SmoothCool HR System

Applicant Jeisys Medical, Inc.

K-Number K213484

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QQC 2022-04-19

Brainlab Elements Guide XT, Guide 3.0

Applicant Brainlab AG

K-Number K213930

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DQX 2022-04-19

Spartan Center Wire

Applicant Spartan Micro, Inc.

K-Number K220075

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NUH 2022-04-19

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K-Number K220152

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GKA 2022-04-19

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

Applicant Helena Laboratories, Corp.

K-Number K192931

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HQC 2022-04-19

QUATERA 700

Applicant Carl Zeiss Meditec, AG

K-Number K212241

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KPR 2022-04-19

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

Applicant Xera Medical Systems & Technology , Ltd.

K-Number K220149

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OVD 2022-04-19

Altus Spine Interbody Standalone Fusion System

Applicant Altus Partners, LLC

K-Number K211837

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NKG 2022-04-19

Infinity™ OCT System and PASS OCT Spinal System

Applicant Medicrea International

K-Number K220810

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NDN 2022-04-18

KYPHON VuE Bone Cement

Applicant Tecres S.P.A.

K-Number K220131

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LCM 2022-04-18

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

Applicant Psychemedics Corporation

K-Number K212952

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JAA 2022-04-18

Nautilus

Applicant Dornier Medtech America, Inc.

K-Number K220871

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