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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

Uterine Aspiration Set

Gcmedica Enterprise Ltd.(Wuxi)

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imip

Thermo Fisher Scientific

Talon Transseptal Sheath

Inari Medical, Inc.

C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor

Nanjing Jusha Display Technology Co., Ltd.

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Si-Technology, LLC

808nm semiconductor laser hair removal machine

Xi'An Taibo Electronic Technology Co., Ltd.

Normatec Go

NormaTec Industries, LP

Power wheelchair (N6101)

Zhejiang Zhonglei Medical Technology Co. , Ltd.

SKR 3000

Konica Minolta, Inc.

Ziehm Vision RFD

Ziehm Imaging GmbH

InstruSafe Instrument Protection System

Summitt Medical, LLC

CastleLoc Pectus Bar System

L&K BIOMED Co., Ltd.

UroNav 4

Philips DS North America, LLC

ClearCalc Model RADCA V2.6

Radformation, Inc.

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System

Synthes GmbH

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibro

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech wi

Medline Industries, LP

Cardiovascular Angiography System

Allengers Medical Systems Limited

QardioArm 2

Qardio, Inc.

Flyte

Pelvital USA, Inc.

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Sorin Group Italia S.R.L.

IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507B

Shenzhen Xiazhifeng Electronic Co., Ltd.

CyClean Cord

SS GLOBAL

cobas CMV

Roche Molecular Systems, Inc.

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

Megin OY

Primescan 2

Dentsply Sirona, Inc.

LIAISON NES FLU A/B, RSV & COVID-19

Diasorin Molecular, LLC

Trigon™ HA Stand-Alone Wedge Fixation System

Nvision Biomedical Technologies, Inc.

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

W. L. Med Co., Ltd.

Neodent Implant System - GM Narrow Implant System

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

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