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

CAZ 2020-12-29

E-Cath STIM acc. Tsui

Applicant PAJUNK GmbH Medizintechnologie

K-Number K202699

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DSH 2020-12-29

M5 Recorder

Applicant Global Instrumentation, LLC

K-Number K202456

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QHH 2020-12-29

First Relief v1

Applicant Dyansys, Inc.

K-Number K202940

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QHE 2020-12-28

Smart SPACE Shoulder System

Applicant Techmah Medical, LLC

K-Number K202454

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FRC 2020-12-28

Self-Contained Biological Indicator

Applicant True Indicating, LLC

K-Number K200970

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MQV 2020-12-28

Uni-FuZe-P Bone Putty

Applicant Zavation Medical Products, LLC

K-Number K201781

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FRF 2020-12-28

Novaerus NV1050

Applicant Novaerus Us, Inc.

K-Number K200321

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ODP 2020-12-28

Tailored-C Cervical Interbody Fusion System

Applicant Bespoke Technologies

K-Number K200458

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EHD 2020-12-28

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

Applicant Nanoray Co., Ltd.

K-Number K201800

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KDI 2020-12-28

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K203062

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CBI 2020-12-28

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

Applicant Insung Medical Co., Ltd.

K-Number K200968

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JWH 2020-12-28

Attune Revision Sleeve LPS Femoral Adaptors

Applicant Depuy Ireland UC

K-Number K202248

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