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

OVE 2020-09-18

Seaspine WaveForm C Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K201073

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GXN 2020-09-18

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

Applicant Synthes (USA) Products, LLC

K-Number K192702

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DTZ 2020-09-18

Paragon Adult Maxi PMP Oxygenator with Tubing Pack

Applicant Chalice Medical , Ltd.

K-Number K201642

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KIF 2020-09-18

DIA-ROOT BIO MTA

Applicant DiaDent Group International

K-Number K200174

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LZC 2020-09-18

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industires, Inc.

K-Number K201390

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OSP 2020-09-18

LaborView LV1000 Wireless Electrode System

Applicant Obmedical Company

K-Number K190798

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JWH 2020-09-18

GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)

Applicant Medacta International S.A.

K-Number K202022

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FPA 2020-09-18

Intellifuse Administration and Intellifuse Blood Administration Sets

Applicant Smiths Medical Asd, Inc.

K-Number K192375

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OQB 2020-09-18

Spineology Interbody Fusion System

Applicant Spineology, Inc.

K-Number DEN200010

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LLZ 2020-09-18

EchoPAC Software Only, EchoPAC Plug-In

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200852

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KTT 2020-09-18

Smart Correction System

Applicant Wishbone Medical, Inc.

K-Number K193368

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LPL 2020-09-18

Optixon 1-Day

Applicant Optixon, Inc.

K-Number K201013

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