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

PHX 2022-04-21

INHANCE Reverse Shoulder System

Applicant Depuy Ireland UC

K-Number K212737

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QEY 2022-04-20

EKOS+ Endovascular Device

Applicant Boston Scientific

K-Number K220866

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OAP 2022-04-20

Auxo A300, A150 and APod

Applicant Auxo Hair, LLC

K-Number K220543

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DPW 2022-04-20

GEM FLOW COUPLER Monitor (GEM1020M-2)

Applicant Synovis Micro Companies Alliance, Inc.

K-Number K213974

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QKM 2022-04-20

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Company

K-Number K212022

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GCJ 2022-04-20

Saberscope5 Laparoscope

Applicant Xenocor, Inc.

K-Number K220872

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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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