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
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Intradin (Shanghai) Machinery Co., Ltd.
nView s1 with nav option
Nview Medical
CROSSLEAD 0.018inch
Asahi Intecc Co., Ltd.
FloPatch FP120
Flosonics Medical
PLANET Onco Dose (3.2)
Dosisoft SA
Ez3D-i/E3
Ewoosoft Co., Ltd.
Molecular Transport Media - MTM
Alb Luz
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
Centinel Spine, LLC
SiOxD® Wound Matrix
Sioxmed, LLC
Klarity SRS Baseplate, Klarity Promise Baseplate
Klarity Medical & Equipment (GZ) Co., Ltd.
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Iridex Corporation
MAASTRO Rectal Applicator Set
Varian Medical Systems
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
H.S Hospital Service S.P.A
T3 Platform software
Etiometry, Inc.
NeuroQuant
Cortechs Labs, Inc.
Disposable Medical Mask
Jiangsu Nanfang Medical Co., Ltd.
Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Venclose, Inc.
Overjet CBCT Assist
Overjet, Inc.
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve T
Spectrum Vascular
Straumann® PURE Ceramic Implants
Institut Straumann AG
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Guangdong Jinme Medical Technology Co., Ltd.
Xpert Wrist
Newclip Technics
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
Ningbo Maxcon Medical Technology Co., Ltd.
AG100s
Hospitech Respiration , Ltd.
SKOUT® system
Iterative Scopes, Inc.
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
Heidelberg Engineering GmbH
SureSmile Aligner (ASSY500020)
Dentsply Sirona, Inc.
T65 (9016E061-)
Tonica Elektronik A/S
Dental X-RAY Unit (AJX200)
Guangzhou Ajax Medical Equipment Co., Ltd.
VicorderCS (VCS-SYS-1100)
80 Beats Medical GmbH
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