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

OVE 2021-05-10

ChoiceSpine Blackhawk Ti Cervical Spacer System

Applicant Choice Spine, LLC

K-Number K203311

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LYZ 2021-05-10

Single-use medical poly (vinyl chloride) examination glove

Applicant Anhui Bytech Medical Supplies Co., Ltd.

K-Number K201504

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KCT 2021-05-07

Karl Storz Radel Sterilization Trays

Applicant Karl Storz Endoscopy America, Inc.

K-Number K203572

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LZA 2021-05-07

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210366

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LZA 2021-05-07

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

Applicant Central Medicare Sdn Bhd

K-Number K203036

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QLG 2021-05-07

Bigfoot Unity Diabetes Management System

Applicant Bigfoot Biomedical, Inc.

K-Number K202145

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FXX 2021-05-07

SURGICAL MASK, Model Name:C015

Applicant Qingdao Hainuo Biological Engineering Co., Ltd.

K-Number K210218

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LZA 2021-05-07

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

Applicant Meditech Gloves Sdn Bhd

K-Number K210755

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JDR 2021-05-07

FuseForce Flex Dynamic Compression System

Applicant Wright Medical

K-Number K203832

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JOW 2021-05-07

Reprocessed Tri Pulse Compression Garment

Applicant Renu Medical, Inc.

K-Number K203847

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LLZ 2021-05-06

ImagePilot

Applicant Konica Minolta, Inc.

K-Number K210066

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GEI 2021-05-06

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

Applicant Bolder Surgical, LLC

K-Number K203183

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