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510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Synguard Nitrile Exam Glove

Tianjin Aoshang Outdoor Equipment Co., Ltd.

Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Nee

Jiangsu Micsafe Medical Technology Co., Ltd.

TENS device-HeadaTerm 2 (Model: YF-HT2)

Wat Medical Technology, Inc.

Pentax Medical Valve Set

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

Atmos Medizintechnik GmbH & Co. KG

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

Zevex, Inc.

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Owl Night Guard

Owl Dental Lab, Inc.

Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) Syst

Dexcom, Inc.

FibriCheck

Qompium NV

Artisan Bone Plug, Universal Cement Restrictor

Howmedica Osteonics, Dba Stryker Orthopaedics

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

Hangzhou AllTest Biotech Co., Ltd.

Sterile PHALINX Hammertoe System

Wrightmedicaltechnologyinc

Dental Zirconia Ceramic

Aidite (Qinhuangdao) Technology Co., Ltd.

Compact II

Enraf-Nonius, B.V.

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-01

Zhenjiang Assure Medical Equipment Co., Ltd.

CAPRI

ORO Co., Ltd.

Spirobank Oxi

Mir Medical International Research USA

Jplant

Jj Medical Co., Ltd.

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

Vivachek Biotech (Hangzhou) Co., Ltd.

ZEPTO Precision Capsulotomy System

Centricity Vision, Inc.

FMS VUE™ Fluid Management and Tissue Debridement System

DePuy Mitek, Inc.

PerfusionGo Plus

Yukun (Beijing) Technology Co., Ltd.

Promogran Prisma™ Collagen Matrix with ORC and Silver

Solventum Germany GmbH

MeVis Liver Suite

MeVis Medical Solutions AG

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Healgen Scientific,, LLC

XENOVIEW 3.0T Chest Coil

Polarean, Inc.

PainFreeze II

Nuance Medical, LLC

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

Fujifilm Corporation

SPARK Scan

Spark Neuro, Inc.

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