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

GJS 2022-10-05

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Applicant Coagusense, Inc.

K-Number K212779

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KFF 2022-10-04

HemosIL Liquid Anti-Xa

Applicant Instrumentation Laboratory CO

K-Number K213464

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QEW 2022-10-04

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

Applicant Penumbra, Inc.

K-Number K220683

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CAF 2022-10-04

Hailie Sensor NF0107 & NF0108

Applicant Adherium (Nz), Ltd.

K-Number K221994

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NKB 2022-10-04

CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K221646

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FMF 2022-10-04

Sterile Hypodermic Syringes for Single Use

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221079

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FMI 2022-10-04

Sterile Safety Hypodermic Needles for Single Use

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221080

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MEG 2022-10-04

Sterile Hypodermic Syringes for Single Use with Safety Needles

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221073

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JWH 2022-10-04

TriVerse Total Knee Replacement System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K222380

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OLO 2022-10-04

ROSA® Knee System

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K221928

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FMI 2022-10-04

Sterile Hypodermic Needles for Single Use

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221066

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LPL 2022-10-04

POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens

Applicant INTEROJO, Inc.

K-Number K221517

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