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

HTN 2024-08-01

TACTIX Vector Syndesmosis System

Applicant Vilex, LLC

K-Number K240035

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SBY 2024-08-01

PGDx elio plasma focus Dx

Applicant Personal Genome Diagnostics, Inc.

K-Number DEN230046

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PGY 2024-08-01

3MP Color LCD Monitor (CL-S301)

Applicant Jvckenwood Corporation

K-Number K241105

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MEH 2024-08-01

Logical Liner; World Liner; World Knee Patella

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K241690

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NKB 2024-08-01

CarboClear® X Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K233793

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JWH 2024-08-01

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K-Number K242046

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EZL 2024-08-01

Rüsch Latex Gold Foley Catheter

Applicant Teleflexmedical, Inc.

K-Number K232469

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HCC 2024-08-01

A Breathing System (ABS)

Applicant Deepwell Dtx, Inc.

K-Number K233580

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MHX 2024-08-01

Infinity CentralStation Wide

Applicant Draeger Medical Systems, Inc.

K-Number K240312

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HIR 2024-08-01

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Applicant Pelvital USA, Inc.

K-Number K240805

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FGB 2024-08-01

KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

Applicant Karl Storz SE & CO. KG

K-Number K241945

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HSB 2024-08-01

DePuy Synthes Retrograde Femoral Nail Advanced System

Applicant DePuy Synthes

K-Number K233696

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