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
Vektor Computational ECG Mapping System (vMap®)
Vektor Medical, Inc.
ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCu
Medtronic Xomed, Inc.
Stethophone
Sparrow Acoustics, Inc.
ATM Glove
Phu Duc Huy Production Trading Services Corporation
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Olympus Medical Systems Corporation
ArcSP Suprapubic Sling System
Urocure, LLC
Dynamic TiBase
Talladium España, SL
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Mercator Medical (Thailand), Ltd.
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Jieshi Medical Products Co., Ltd.
Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
Alliage S/A Industrias Médico Odontológica
Aerin Console
Aerin Medical, Inc.
Prostate Core
Lucida Medical, Ltd.
Pixyl.Neuro
Pixyl SA
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002A
Shenzhen Fansizhe Science and Technology Co., Ltd.
Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
Dr. Yglo Skin Tag Remover
Theotclab Healthcare B.V.
DS Core CBCT Anatomy
Dentsply Sirona
VitroPRO
CIVCO Medical Instruments Co., Inc.
FIX-L PEEK PLIF and T-PLIF System
Jeil Medical Corporation
ProLift Micro Expandable Spacer System
Life Spine, Inc.
OK Handpiece
Jaintek Co.,Ltd
BA-004CC
Fujifilm Corporation
F&P Evora Full Face Mask
Fisher & Paykel Healthcare, Ltd.
Stryker Resorbable Fixation System
Stryker Leibinger Micro Implants
Syngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH
Oxygen Concentrator
Foshan Mic Medical Technology Co., Ltd.
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Riverstone Resources Sdn Bhd
Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair R
Guangzhou Chuang Zao Mei Technology Co., Ltd.
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
Life Spine, Inc.
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