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

OHT 2024-09-09

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K241205

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NKB 2024-09-09

Pitkar Spinal Pedicle Screw System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K240233

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QIH 2024-09-09

Overjet Image Enhancement Assist

Applicant Overjet, Inc.

K-Number K241681

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MQB 2024-09-09

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)

Applicant Rayence Co., Ltd.

K-Number K242394

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NKB 2024-09-09

TriALTIS Spine System

Applicant Medos International SARL

K-Number K242042

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NUH 2024-09-09

TENS & EMS Stimulator (MHD-1083)

Applicant Shenzhen Minghuangda Electronics Co., Ltd.

K-Number K241678

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LYY 2024-09-09

Latex Examination Glove Powder Free (Ocean Blue and Natural White)

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K240266

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QDQ 2024-09-09

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

Applicant See-Mode Technologies Pte, Ltd.

K-Number K240697

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LJS 2024-09-08

PM2 System and ECGuide Connector

Applicant Piccolo Medical, Inc.

K-Number K240486

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OAS 2024-09-06

T2 Plus

Applicant Osstem Implant Co., Ltd.

K-Number K233806

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HQF 2024-09-06

VISULAS combi

Applicant Carl Zeiss Meditec, AG

K-Number K233911

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MNR 2024-09-06

Withings Sleep Rx

Applicant Withings

K-Number K231667

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