Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

NUC 2021-11-23

Playboy Premium Silicone Lubricant

Applicant Thai Nippon Rubber Industry Public Company Limited.

K-Number K210095

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CIX 2021-11-23

Albumin BCG2

Applicant Abbott Ireland Diagnostics Division

K-Number K203248

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PWH 2021-11-23

PCEA Syringe Set

Applicant Baxter Healthcare Corporation

K-Number K211649

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FGB 2021-11-23

Uretero1 Ureteroscope System

Applicant STERIS Corporation

K-Number K211347

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BZQ 2021-11-23

Breathe Easy Mobile Respiratory Monitor (MRM)

Applicant Sound Life Sciences, Inc.

K-Number K211387

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GEI 2021-11-23

Virtue RF

Applicant ShenB Co., Ltd.

K-Number K211562

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OLP 2021-11-23

MZ Skin LightMAX Supercharged LED Mask 2.0

Applicant Mz Skin

K-Number K213184

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FYA 2021-11-23

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown

Applicant Cardinal Health, LLC

K-Number K211765

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DXG 2021-11-23

Hypotension Decision Assist Model HDA-OR2

Applicant Directed Systems, Ltd.

K-Number K212529

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IRP 2021-11-23

Air compression therapy system FO3002

Applicant Foshan Hongfeng Co., Ltd.

K-Number K212169

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LQP 2021-11-23

Sofia 2 Campylobacter FIA

Applicant Quidel Corporation

K-Number K211342

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HIH 2021-11-23

Hystero-V Hysteroscope

Applicant Hysterovue, Inc.

K-Number K202445

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