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
OptoMonitor 3
Opsens, Inc.
HemosIL Liquid Anti-Xa
Instrumentation Laboratory CO
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
Deltronix Equipamentos Ltda
Venus Cervical Plate System
Artfx Medical, LLC
Brainlab Elements Guide XT, Guide 3.0
Brainlab AG
Disposable Medical Masks
Hantech Medical Device Co., Ltd.
Versius Surgical System (Versius Plus)
Cmr Surgical Limited
Armis VeriCyn Wound Wash
Armis Biopharma, Inc.
HyperSuture Extension Line
Threadstone, LLC
Multi M Series
Dmax Co., Ltd.
Phoenix Sinus Tarsi Stent System
Astra Orthomed, Inc.
Disposable Injection Needles
Ningbo Xinwell Medical Technology Co., Ltd.
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB
Joytech Healthcare Co. , Ltd.
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Wuhan Pioon Technology Co., Ltd.
CellFX System
Pulse Biosciences, Inc.
Remex Spine Surgery Navigation Instrument
Remex Medical Corp.
Electric wheelchair (XW-LY007 )
Yongkang Ruihe Metal Product Co., Ltd.
QIAstat-Dx BCID GN Plus AMR Panel
QIAGEN GmbH
Primescan 2
Dentsply Sirona, Inc.
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
First Source, Inc.
Surgical Mask
Wuhan Zonsen Medical Products Co., Ltd.
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc.
PureLift GLOW
Xtreem Pulse, LLC
Access CK-MB
Beckman Coulter, Inc.
Revogene
Meridian Bioscience, Inc.
Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
Argos Infinity (Rev. 1.0)
Retia Medical Systems, Inc.
Arthrex Self-Punching PushLock Suture Anchor
Arthrex, Inc.
autoSCORE
Holberg Eeg AS
Hair Regrowth Cap (Model: T-119-HRC)
Light Tree Ventures Europe B.V.
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