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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