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

ODP 2026-01-14

Cervical Interbody and VBR Fusion System

Applicant Sync Surgical

K-Number K252219

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LZC 2026-01-14

Cardinal Health Nitrile Examination Gloves Extended Cuff

Applicant Cardinalhealth

K-Number K252313

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OXO 2026-01-14

Orthoscan TAU MVP Mini C-Arm System

Applicant Ziehm-Orthoscan, Inc.

K-Number K252579

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MOS 2026-01-14

dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

Applicant Philips Medical Systems Nederland B.V.

K-Number K254190

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KRD 2026-01-14

Concerto Versa Detachable Coil

Applicant Medtronic, Inc.

K-Number K253511

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QNI 2026-01-13

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Applicant Miach Orthopaedics, Inc.

K-Number K251214

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GCJ 2026-01-13

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Applicant Stryker Endoscopy

K-Number K254014

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KPS 2026-01-13

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K254001

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NKB 2026-01-13

Swedge Pedicle Screw Fixation System Bezier Rod

Applicant Spinal Resources, Inc.

K-Number K252461

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LZA 2026-01-13

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

Applicant Kossan International Sdn Bhd

K-Number K252549

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EJK 2026-01-13

Bright Cavity Liner

Applicant Dmp Dental Industry S.A.

K-Number K253248

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GEI 2026-01-12

Boston iFace (Boston iFace)

Applicant Boston Aesthetics, Inc.

K-Number K251988

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