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

EBG 2022-03-10

Hexa-Temp

Applicant Spident Co., Ltd.

K-Number K214071

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HWC 2022-03-10

SIGNUS SACRONAIL® Transsacral Stabilization System

Applicant Signus Medizintechnik GmbH

K-Number K212755

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SBF 2022-03-10

NextAR™ TKA Platform My Knee PPS

Applicant Medacta International S.A.

K-Number K213751

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FRG 2022-03-10

Sterilization Wraps

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K-Number K220133

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NZA 2022-03-10

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

Applicant STERIS Corporation

K-Number K220361

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LZA 2022-03-10

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs

Applicant Ansell Healthcare Products, LLC

K-Number K212148

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LJE 2022-03-10

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

Applicant Coloplast Corp.

K-Number K211911

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PNE 2022-03-10

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

Applicant Innovative Health, LLC

K-Number K212165

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LZC 2022-03-10

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K213910

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JGS 2022-03-10

GLP systems Track

Applicant Abbott Laboratories

K-Number K213486

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LZA 2022-03-10

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K213373

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FLL 2022-03-10

Infrared Forehead Thermometer, model: HS-9802D

Applicant Jiaxing Shangjia Intelligence Technology Co., Ltd.

K-Number K213038

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