FDA activity / Device clearances and approvals

Device clearances and approvals: the latest from FDA

510(k), De Novo and new PMA approvals. About 63 a week over the last 4 weeks FDA has published, 29 of them from US companies. Latest: October 2, 2026.

63a week

29US companies a week

253in 4 weeks

Per week

21Aug 31–Sep 6
70Sep 7–Sep 13
86Sep 14–Sep 20
76Sep 21–Sep 27

By pathway

510(k)250
PMA3

The latest

Date	Company	Product	Class	Where
Oct 2	Roche Diagnostics	Elecsys EBV VCA IgG	Class I	Indianapolis, IN
Oct 2	GE Medical Systems Ultrasound and Primary…	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	Class II	Waukesha, WI
Oct 2	OsteoCentric Technologies	OsteoCentric Technologies Cannulated and Soild Fasteners…	Class II	Logan, UT
Oct 2	Tdm Co., Ltd.	TDM Large Bone Plate and Screw System	Class II	Gwangju, South Korea
Oct 2	Roche Diagnostics	Elecsys EBV EBNA IgG	Class I	Indianapolis, IN
Oct 2	Cepheid®	Xpert Xpress CoV-2/Flu plus	Class II	Sunnyvale, CA
Oct 2	Remedi, Inc.	REMEX-T(K)100C	Class II	Seoul, South Korea
Oct 2	GE Medical Systems Ultrasound & Primary…	Lung Guidance	Class II	Waukesha, WI
Oct 2	Response Ortho Solutions, LLC	Response Ortho Smart Fixator - Hexapod System	Class II	Boynton Beach, FL
Oct 2	VPIX Medical, Inc.	cCeLL405	Class II	Daejeon, South Korea
Oct 2	Argus Cognitive, Inc.	Neurora	Class II	Hanover, NH
Oct 2	Shenzhen Ninenovo Technology Limited	Ninenovo Blood Oxygen Ring…	Class II	Shenzhen, China
Oct 2	Spinal Simplicity, LLC	Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion…	Class II	Overland Park, KS
Oct 2	Lg Electronics.Inc	Medical Monitor (32MD08WC)	Class II	Gumi-Si, South Korea
Oct 2	Steris	MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor	Class II	Mentor, OH

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