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

NKB 2020-12-17

ARx Illiac Spinal Screw System

Applicant Life Spine, Inc.

K-Number K203163

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LJE 2020-12-17

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

Applicant Coloplast Corp.

K-Number K201165

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OAT 2020-12-17

Blue Sky Bio TAD

Applicant Blue Sky Bio, LLC

K-Number K201919

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OWN 2020-12-17

KARL STORZ ICG Imaging System

Applicant Karl Storz Endoscopy_America, Inc.

K-Number K202925

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DXT 2020-12-17

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

Applicant Acist Medical Systems, Inc.

K-Number K203004

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EOQ 2020-12-17

Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L

Applicant Olympus Medical Systems Corp.

K-Number K200342

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ITI 2020-12-17

Electric wheelchair (Model: S7012)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K200857

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HRS 2020-12-16

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Applicant DePuy Synthes

K-Number K203414

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QEH 2020-12-16

NRFit® Caps, Male and Female Neuraxial Tip Caps

Applicant International Medical Industries, Inc.

K-Number K201031

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QNI 2020-12-16

BEAR (Bridge-Enhanced ACL Repair) Implant

Applicant Miach Orthopaedics, Inc.

K-Number DEN200035

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NEU 2020-12-16

HydroMARK Breast Biopsy Site Markers

Applicant Devicor Medical Products, Inc.

K-Number K203097

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JDR 2020-12-16

Arthrex DynaNite Nitinol Staples

Applicant Arthrex, Inc.

K-Number K203180

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