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
Access Cortisol; DxC 500i Clinical Analyzer
Beckman Coulter, Inc.
eZSURE Empty Fluid Container
Epic Medical Pte. , Ltd.
MARVEL Growing Rods
Globus Medical, Inc.
FlareHawk Interbody Fusion System
Integrity Implants Inc. Dba Accelus
Electrocardiograph
Edan Instruments, Inc.
Surgical Masks
Hubei Xinxin Non-Woven Co., Ltd.
Edison System
HistoSonics, Inc.
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced De
Boston Scientific Corporation
Francisella tularensis Real-time PCR assay
Centers for Disease Control and Prevention
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
Smith & Nephew, Inc.
Power wheelchair (N6101)
Zhejiang Zhonglei Medical Technology Co. , Ltd.
Mochida Nerve Cuff
Mochida Pharmaceutical Co., Ltd.
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
Howmedica Osteonics Corp. dba Stryker Orthopaedics
Respond OC Conserving Regulator (130-0800)
Responsive Respiratory
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
Beijing Konted Medical Technology Co.,Ltd
EMPHASYS Acetabular System
Depuy Ireland UC
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Nihon Kohden Corporation
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Cefla S.C.
Socrates 38 Catheter
Scientia Vascular, Inc.
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
Acist Medical Systems, Inc.
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
Ningxia Qiaoen Medical Technology Co., Ltd.
HOLLYWOOD SPECTRA Laser System
Lutronic Corporation
Eversense AP CGM System
Senseonics, Incorporated
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Montross Extremity Medical Hemi Implant System
Montross Extremity Medical
Hemoclip
Hangzhou AGS MedTech Co., Ltd.
Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics
Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314,
Shenzhen Yimi Life Technology Co., Ltd.
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
Shenzhen Nuon Medical Equipment Co., Ltd.
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