ClearanceBrief

Latest 510(k) clearances

Newest first, 50 per page. Open a clearance to see any recalls that name it.

Decided510(k)Device and applicantCode
Oct 6, 2026K261938APRO 88 Catheter
Alembic, LLC
QJP
Oct 6, 2026K261887Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-
NormaTec Industries, LP
IRP
Oct 6, 2026K261200Power Wheelchair (D60)
Anhui JBH Medical Apparatus Co., Ltd., CN
ITI
Oct 6, 2026K261141OpenFlo Urinary Catheter
Urolution Medical, Inc.
EZL
Oct 6, 2026K261079Power Wheelchair (DC12)
Anhui JBH Medical Apparatus Co., Ltd., CN
ITI
Oct 6, 2026K260136Forza
True Function Laboratory, Inc.
LRK
Oct 5, 2026K262813InkSpace Imaging Small Body Array (SBA12PH15x)
Inkspace Imaging, Inc.
MOS
Oct 5, 2026K262812Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-
Sichuan Qianli-Beoka Medical Technology, Inc., CN
IRP
Oct 5, 2026K262285UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
Shijiazhuang Recovery Star Medical Device Co., Ltd., CN
FTC
Oct 5, 2026K261939Glucommander
Glytec, LLC
NDC
Oct 5, 2026K261655RT Elements (4.6)
Brainlab SE, DE
MUJ
Oct 5, 2026K260523QGuideCT (1.0)
Medis Medical Imaging Systems BV, NL
QIH
Oct 5, 2026K260005MyoVista wavECG (DG-200-B15-003)
HeartSciences, Inc.
DPS
Oct 2, 2026K263120Xpert Xpress CoV-2/Flu plus
Cepheid®
QOF
Oct 2, 2026K263116OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
OsteoCentric Technologies
HWC
Oct 2, 2026K263113ZSAlign Cervical Interbody System
ZSFab, Inc.
OVE
Oct 2, 2026K263086AltiVate Reverse® Glenosphere with RAVN™ Technology
Encore Medical L.P.
PHX
Oct 2, 2026K263083Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC
KTT
Oct 2, 2026K262985Medical Monitor (32MD08WC)
Lg Electronics.Inc, KR
PGY
Oct 2, 2026K262412Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)
Barco NV, BE
PGY
Oct 2, 2026K261943REMEX-T(K)100C
Remedi, Inc., KR
IZL
Oct 2, 2026K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
IYN
Oct 2, 2026K261791MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor
Steris
FEB
Oct 2, 2026K261783Plenity-V (MC0979 / GS110)
Gelesis SRL, IT
QFQ
Oct 2, 2026K261741Hemostatic Clip
Anrei Medical (Hz) Co., Ltd., CN
PKL
Oct 2, 2026K261611TDM Large Bone Plate and Screw System
Tdm Co., Ltd., KR
HRS
Oct 2, 2026K261607Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion
Spinal Simplicity, LLC
PEK
Oct 2, 2026K261217AnyPlus II Spinal Fixation System
GS Medical Co., Ltd., KR
NKB
Oct 2, 2026K261042Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
QJU
Oct 2, 2026K260689CVS Advanced PLUS Blood Glucose Monitoring System
I-Sens, Inc., KR
NBW
Oct 2, 2026K260490Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,
Shenzhen Ninenovo Technology Limited, CN
DQA
Oct 2, 2026K260487stentFIX System Set (100.50n)
Ovesco Endoscopy AG, DE
PKL
Oct 2, 2026K260468H100Plus Hemoglobin Testing System
Shenzhen Lifotronic Technology Co., Ltd., CN
PDJ
Oct 2, 2026K260233Elecsys EBV IgM
Roche Diagnostics
LJN
Oct 2, 2026K260232Elecsys EBV VCA IgG
Roche Diagnostics
LSE
Oct 2, 2026K260221Elecsys EBV EBNA IgG
Roche Diagnostics
LSE
Oct 2, 2026K260064Neurora
Argus Cognitive, Inc.
QPF
Oct 2, 2026K260044Ventricular Catheters, Thomale Catheter
Aesculap, Inc.
JXG
Oct 2, 2026K254030cCeLL405
VPIX Medical, Inc., KR
QFX
Oct 2, 2026K253422OAB Delivery Catheter
Cognition Medical Corp.
QJP
Oct 1, 2026K263092Dual Stage Venous Cannulae
Sorin Group Italia S.R.L., IT
DWF
Oct 1, 2026K263062NOVIX Pedicle Screw System
Tdm Co., Ltd., KR
NKB
Oct 1, 2026K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary System
Centerline Biomedical
DQK
Oct 1, 2026K262473NEXUS® Hip Stem
Microport Orthopedics, Inc.
LZO
Oct 1, 2026K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemo
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Oct 1, 2026K261612SwiftSight-BodyComposition
Airs Medical, Inc., KR
LNH
Oct 1, 2026K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205,
Shenzhen Brav Electronic Technologies Co., Ltd., CN
DXN
Oct 1, 2026K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
bioMerieux, Inc.
LON
Oct 1, 2026K260029Firstar Dental Handpieces
FDC Technology Industry Co.
EFB
Oct 1, 2026K260027Firstar Dental Electric Motor
FDC Technology Industry Co.
EBW