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

OXZ 2019-09-17

Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)

Applicant Amd Medicom, Inc.

K-Number K190308

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ODC 2019-09-17

Bio Guard Air/Water & Suction Valves

Applicant United States Endoscopy Group, Inc.

K-Number K192059

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LRK 2019-09-17

Sapphire Dorsal Comfort Fit

Applicant Crane Dental Laboratory, Inc.

K-Number K181416

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LPL 2019-09-17

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Applicant Unicon Optical Co., Ltd.

K-Number K191929

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GEX 2019-09-17

Discovery Pico, Discovery Pico Plus, Discovery Pico Derm

Applicant Quanta System Spa

K-Number K191842

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DRF 2019-09-17

Advisor VL Circular Mapping Catheter, Sensor Enabled

Applicant ABBOTT MEDICAL

K-Number K192037

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ODP 2019-09-17

HEDRON Cervical Spacers

Applicant Globus Medical, Inc.

K-Number K191243

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OLP 2019-09-17

Poly Clear

Applicant Medtek Skincare, LLC

K-Number K183708

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PZO 2019-09-17

Sim&Size

Applicant Sim&Cure

K-Number K190049

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LZA 2019-09-16

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

Applicant Kossan International Sdn Bhd

K-Number K191800

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NKB 2019-09-16

Mercury® Spinal System, Overwatch® Spinal System

Applicant Spinal Elements, Inc.

K-Number K191576

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GEX 2019-09-16

PicoWay Laser System

Applicant Candela Corporation

K-Number K191685

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