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
Multi-parameter detector
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
ExcelsiusFlex
Globus Medical, Inc.
Patient Monitor (iX10, iX12, iX15)
Edan Instruments, Inc.
s-Clean Link Abutment
Dentis Co., Ltd.
iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
Ihealth Labs, Inc.
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Technology Co., Ltd.
Extended Reservoir; MiniMed Reservoir
Medtronic Minimed
Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
Cook Medical
NxtGen Infant Transport Incubator
International Biomedical
Galaxy System
Noah Medical Corp.
Celsio Flexible Cryocatheter System
Endocision Technologies, Inc.
Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd
Logic Hd camera head green, System green
Richard Wolf Medical Instruments Corporation
Electric Nasal Aspirator (BC026, BC025, BC023)
Shenzhen Kingboom Technology Co., Ltd.
SI-Cure Sacroiliac Joint Fusion System
Alevio, LLC
Spinery RF Ablation System
Axon Spine Medical System
ORi
Masimo Corporation
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
MacroLux Medical Technology Co., Ltd.
ClearCap Distal Attachment
Finemedix Co., Ltd.
ONVOY Acetabular System
Globus Medical, Inc.
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
Telefield Medical Imaging (Shenzhen) Limited
cryo-GO Vitrification Device
Fujifilm Irvine Scientific
ALLY Adaptive Cataract Treatment System
Lensar, Inc.
Ascent3T Neonatal Magnetic Resonance Imaging System
Eyas Medical Imaging, Inc.
Venclose digiRF Generator (VCRFG1)
Venclose, Inc.
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citra
Ksg Medicare Sdn. Bhd.
AIAS Cephalon
Metamorphosis GmbH
da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
R:GEN
Lutronic Vision, Inc.
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