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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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