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

GAT 2017-08-22

GRAVITY Soft Tissue Repair System

Applicant Wrightmedicaltechnologyinc

K-Number K170642

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FRC 2017-08-22

VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

Applicant STERIS Corporation

K-Number K171587

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GEI 2017-08-22

Stryker Integrated Bipolar Cord and Tubing Sets

Applicant Stryker Instruments

K-Number K172367

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GEI 2017-08-22

Monopolar Single Use Laparoscopic Instrument

Applicant Getsch+Hiller Medizintechnik GmbH

K-Number K171523

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OAP 2017-08-22

Grivamax Hair Growth System

Applicant Leana Orders, Inc.

K-Number K171895

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LLZ 2017-08-22

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K-Number K172364

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KFF 2017-08-22

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

Applicant Siemens Healthcare Diagnostics Prodcts GmbH

K-Number K162540

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ODP 2017-08-22

Matrixx System

Applicant Nexxt Spine, LLC

K-Number K171140

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LLZ 2017-08-22

OKI Surgical Planning Software

Applicant Ortho Kinematics, Inc.

K-Number K171617

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JPI 2017-08-22

i-STAT Hematocrit test with i-STAT Alinity System

Applicant Abbott Laboratories

K-Number K163342

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LSR 2017-08-22

Borrelia B31 ViraChip IgM Test Kit

Applicant Viramed Biotech AG

K-Number K163695

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FRO 2017-08-22

NEOCERA Advanced Barrier Cream

Applicant Exeltis USA Dermatology, LLC

K-Number K170911

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