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

LZA 2020-08-20

Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug

Applicant Anhui Lntco Medical Products Co., Ltd.

K-Number K200093

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LCX 2020-08-20

Distinct® Early Detection Pregnancy Test

Applicant ACON Laboratories, Inc.

K-Number K193318

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NHA 2020-08-19

Straumann BLX Gold Abutments

Applicant Straumann USA, LLC (On Behalf of Institut Straumann Ag)

K-Number K200597

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OLI 2020-08-19

invisa-RED ELITE

Applicant IR Technology, LLC

K-Number K192275

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IYO 2020-08-19

CUBEScan BioCon-1100

Applicant Mcube Technology Co., Ltd.

K-Number K201995

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PML 2020-08-19

CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement

Applicant Medtronic

K-Number K201362

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JOW 2020-08-19

VariLymph 12 pro

Applicant Slk Medical GmbH

K-Number K193476

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GGP 2020-08-19

HemosIL von Willebrand Factor Antigen

Applicant Instrumentation Laboratory CO

K-Number K200033

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NLQ 2020-08-19

Medline ReNewal Reprocessed Harmonic ACE+7 Shears

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K193563

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QEW 2020-08-19

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

Applicant Penumbra, Inc.

K-Number K193595

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EBF 2020-08-19

Omnichroma Flow

Applicant Tokuyama Dental Corporation

K-Number K193537

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PNP 2020-08-19

Sirona Dental CAD/CAM System with InLab Software

Applicant Dentsply Sirona

K-Number K200191

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