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

NUC 2016-01-11

K-Y Marilyn Pleasure Gel

Applicant Reckitt Benckiser, LLC

K-Number K151884

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DZE 2016-01-11

PURE Ceramic Implants

Applicant Straumann USA

K-Number K151328

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DYB 2016-01-11

Fortress Introducer Sheath SYstem

Applicant Contract Medical International, GmbH

K-Number K153197

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DQY 2016-01-08

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

Applicant Tni Manufacturing, Inc.

K-Number K152876

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ERL 2016-01-08

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Applicant Karl Storz Endoscopy America, Inc.

K-Number K150969

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LEH 2016-01-08

ONLINE TDM Vancomycin Gen.3

Applicant Roche Diagnostics Operations (Rdo)

K-Number K152245

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NBW 2016-01-08

MyGlucoHealth Wireless System

Applicant Entra Health Systems

K-Number K143169

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EIH 2016-01-08

VINTAGE LD

Applicant Shofu Dental Corporation

K-Number K152392

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MQH 2016-01-08

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

Applicant Cook Incorporated

K-Number K151018

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BZD 2016-01-08

Sapphire

Applicant Respironics, Inc.

K-Number K152356

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LBS 2016-01-08

Direct HDL Cholesterol (HDL)

Applicant Randox Laboratories, Ltd.

K-Number K153435

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OWY 2016-01-08

BioBridge Collagen Matrix

Applicant Fibralign Corporation

K-Number K151083

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