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

LZO 2017-08-17

OMNI Anseris Hip Stem

Applicant Omnilife Science

K-Number K171156

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EZN 2017-08-17

Ureteral Dilators and Percutaneous Nephrostomy Dilators

Applicant Coloplast Corp.

K-Number K170531

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FOZ 2017-08-17

BD Intima II PLUS Closed IV Catheter System

Applicant Becton, Dickinson and Company

K-Number K172204

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LHN 2017-08-17

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

Applicant Ion Beam Applications S.A.

K-Number K163500

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KNS 2017-08-17

Zimmon Needle Knife Papillotome

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K171993

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KNS 2017-08-17

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

Applicant Creo Medical, Ltd.

K-Number K171983

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HQD 2017-08-16

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)

Applicant Visionary Optics, LLC

K-Number K171950

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IYN 2017-08-16

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems

Applicant Siemens Healthcare

K-Number K172162

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EBD 2017-08-16

SHOFU RESIN GLAZE

Applicant Shofu Dental Corporation

K-Number K163568

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NBW 2017-08-16

GLUCOCARD W Blood Glucose Monitoring System

Applicant Arkray Factory, Inc.

K-Number K170064

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DSA 2017-08-16

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

Applicant Integral Process Sas

K-Number K162768

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HSN 2017-08-16

PROPHECY INVISION Pre-operative Navigation System

Applicant Wrightmedicaltechnologyinc

K-Number K170968

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