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

NFO 2023-09-18

BTL-785BNF Handpiece

Applicant BTL Industries, Inc.

K-Number K232172

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DXN 2023-09-18

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)

Applicant Shenzhen Finicare Co., Ltd.

K-Number K231367

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DDR 2023-09-18

Access Myoglobin

Applicant Beckman Coulter, Inc.

K-Number K231832

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MAI 2023-09-18

X-Twist Biocomposite Suture Anchor

Applicant Parcus Medical

K-Number K232513

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OVD 2023-09-18

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System

Applicant Nexus Spine, LLC

K-Number K232530

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QXS 2023-09-18

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

Applicant B.R.A.H.M.S GmbH, Part of Thermo Fisher

K-Number K222251

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FRF 2023-09-18

MA-40, MA-112

Applicant Medify Air, LLC

K-Number K223835

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CAH 2023-09-16

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

Applicant Passy-Muir, Inc.

K-Number K230483

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POM 2023-09-16

ImPACT Version 4

Applicant Impact Applications, Inc.

K-Number K231688

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FDF 2023-09-15

Ambu® aScope™ Colon; Ambu® aBox™ 2

Applicant Ambu A/S

K-Number K230332

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CHL 2023-09-15

i-STAT G3+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K223857

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BSO 2023-09-15

Perifix FX Catheter; Contiplex FX Catheter

Applicant B.Braun Medical, Inc.

K-Number K231242

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