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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

Peak Flow Meter

Chongqing Moffy Innovation Technology Co., Ltd.

Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves

Zibo Langu New Material Technology Co., Ltd.

Compact II

Enraf-Nonius, B.V.

Welch Allyn Connex Central Station

Welch Allyn, Inc.

BioTeke® Multi-Drug Urine Test Cup

Bioteke Corporation (Wuxi) Co., Ltd.

Contour Knee

Quality Electrodynamics, LLC

Healgen® URS Test Strips

Healgen Scientific,, LLC

Percent Oxygen Sensors

Careox, LLC

NIBPCuff

Shenzhen Sino-K Medical Technology Co.,Ltd

Total Wrist Arthroplasty System (TWA)

Skeletal Dynamics

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

Acula Technology Corp.

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Xiamen Probtain Medical Techology Co., Ltd.

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

Wishbone Medical, Inc.

Xpert Xpress CoV-2/Flu/RSV plus

Cepheid®

Device 300397 Putty

Geistlich Pharma AG

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERIT

Spectrum Dynamics Medical, Ltd.

Rusch Intermittent Urethral Catheters

Teleflex Medical

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

Philips Healthcare (Suzhou) Co., Ltd.

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Merit Medical Systems, Inc.

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

Caldera Medical, Inc.

Sonata Transcervical Fibroid Ablation System 2.2

Gynesonics, Inc.

AutoContour (RADAC V6)

Radformation, Inc.

Tigon Medical All-Suture Anchors (ASA)

Tigon Medical

Dong Hai Xiang Surgical Mask

Taizhou Donghaixiang Protective Equipment Co., Ltd.

CO2 Laser System (MBT- CO2 Laser)

Beijing Mega Beauty Technology Co., Ltd.

Kalitec Navigated Instrument System

Kalitec Direct, LLC Doing Business AS Kalitec Medical

Yadu Medical Face Mask (Level 1)

Henan Yadu Industrial Co., Ltd.

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

Hubei Yjt Technology Co.,Ltd

Leonardo Duster

Ceramoptec GmbH

APS Metal Plate & Screw System

A Plus Biotechnology Co., Ltd.

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