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

MAX 2022-08-12

aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices

Applicant Carlsmed, Inc.

K-Number K222082

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OHT 2022-08-12

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17

Applicant Shenzhen Century Dongyuan Technology CO , Ltd.

K-Number K221466

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LLZ 2022-08-12

TeraRecon Neuro

Applicant Terarecon,Inc.

K-Number K220349

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FMK 2022-08-12

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

Applicant Owen Mumford, Ltd.

K-Number K221126

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PLL 2022-08-12

Blue Eye (TS-905)

Applicant The Standard Co., Ltd.

K-Number K220434

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QNP 2022-08-12

SKOUT Software

Applicant Iterative Scopes, Inc.

K-Number K213686

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QTO 2022-08-12

Visibly Digital Acuity Product

Applicant Visibly, Inc.

K-Number K220090

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KPO 2022-08-12

Hemo-Lyte C Cartridge

Applicant Di-Chem, Inc.

K-Number K202508

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JAK 2022-08-11

Medical image processing software

Applicant Hangzhou Deepwise & League of PHD Technology Co., Ltd.

K-Number K220910

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QKQ 2022-08-11

Novo

Applicant PathAI, Inc.

K-Number K212361

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MHX 2022-08-11

Patient Monitor: RespArray

Applicant Edan Instruments, Inc.

K-Number K220308

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PLL 2022-08-11

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)

Applicant Ovesco Endoscopy AG

K-Number K221385

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