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
Aug 5, 2026K260120NaturaJel™ Oral Wound Care Kit
HCS Innovation, LLC
OLR
Aug 5, 2026K254211pVasc Net Mechanical Thrombectomy Device
Vesalio, Inc.
Aug 5, 2026K253858GFS - Sterile Screws and Top Hat
T.A.G. Medical Products Corporation, Ltd., IL
HWC
Aug 5, 2026K252853CAD - Lower GI (EC07-01)
Xiamen Inno Medical Technology Co., Ltd., CN
QNP
Aug 4, 2026K262311Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Aug 4, 2026K261915Navigator™ Flex Ureteral Access Sheath Set
Boston Scientific Corporation
FED
Aug 4, 2026K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+J
Shenzhen Qianyu Technology Co., Ltd., CN
OHS
Aug 4, 2026K261609Freedom Partial Knee System
Maxx Orthopedics, Inc.
HSX
Aug 4, 2026K261523Vertex™ Thrombectomy System
Jupiter Endovascular
QEW
Aug 4, 2026K261496LED Light Therapy Masks (PE748, PE749, PE756)
Duplex International Trading Limited, CN
OHS
Aug 4, 2026K260572Marrow Marxman
Medimetrix, LLC
KNW
Aug 4, 2026K254043TRIVANCE™ Hip Stem
Globus Medical, Inc.
LPH
Aug 4, 2026K253902RealGUIDE
3DIEMME SRL, IT
QIH
Aug 4, 2026K253760OMNI Ultra Surgical System (1-110)
Sight Sciences, Inc.
MRH
Aug 3, 2026K262115VueJect® Ultrasound Enhancing Agent Delivery System
ACIST Medical Systems, Inc.
IZQ
Aug 3, 2026K262047Grappler Suture Anchor System
Paragon 28, Inc.
MBI
Aug 3, 2026K261856Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc.
IYE
Aug 3, 2026K261504PuraStat-RM
3-D Matrix, Inc.
PHN
Aug 3, 2026K261503PuraStat GI
3-D Matrix, Inc.
QAU
Aug 3, 2026K261408SABER-XA System
Elevation Spine
OVD
Aug 3, 2026K260381Eve
Wandercraft SAS, FR
PHL
Aug 3, 2026K260236XLITE
GEMSS HEALTHCARE CO., LTD., KR
IZL
Jul 31, 2026K262681NanoCeram Resin
3BFAB TEKNOLOJI A.S., TR
EBI
Jul 31, 2026K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Orthalign, Inc.
ONN
Jul 31, 2026K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
Globus Medical, Inc.
JWH
Jul 31, 2026K261912SnØreNegatØr
DnB Innovations, LLC
LRK
Jul 31, 2026K261854xvision Spine system
Augmedics, Ltd., IL
SBF
Jul 31, 2026K261824da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc.
NAY
Jul 31, 2026K261810Vertiwedge® Intraosseous System
Foundation Surgical Group
MQP
Jul 31, 2026K261809Interwedge® Standalone Lateral
Foundation Surgical Group
OVD
Jul 31, 2026K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart
Shanghai Hulu Devices Co., Ltd., CN
DQD
Jul 31, 2026K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)
Led Intellectual Properties, LLC
OHS
Jul 31, 2026K261451ZSAlign Cervical Interbody System
ZSFab, Inc.
OVE
Jul 31, 2026K261335VitalFlow Set with Balance™ Biosurface
Medtronic, Inc.
QJZ
Jul 31, 2026K261331I-Genius (100019400)
Esaote, S.p.A., IT
LNH
Jul 31, 2026K261187Hearing Aid Feature
Samsung Electronics Co., Ltd., KR
SCR
Jul 31, 2026K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Olympus Medical Systems Corporation, JP
ODG
Jul 31, 2026K260936RadioViewAI
Neurocareai, Inc. (Dba Savelife.Ai)
LLZ
Jul 31, 2026K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
Siemens Healthineers AG, DE
LNH
Jul 31, 2026K260607Shield System (Siemens 30x40)
Radiaction , Ltd., IL
OWB
Jul 31, 2026K254042WatchPAT SW
Itamar Medical , Ltd., IL
MNR
Jul 31, 2026K253835Affinity
Hermes Medical Solutions AB, SE
QIH
Jul 31, 2026K2538000909FCE, 0909FCE-HS
Rayence Co., Ltd., KR
MQB
Jul 31, 2026K253655Angled Screwdriver MED (M-SD090)
W&H Dentalwerk Bürmoos GmbH, AT
DZI
Jul 31, 2026K253555Flexitouch® Plus Advanced Pneumatic Compression System
Tactile Medical
JOW
Jul 31, 2026K252812UniPearls® Embolic Microspheres
Suzhou Haowei Medical Technology Co., Ltd., CN
KRD
Jul 30, 2026K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down
Stryker Endoscopy
MBI
Jul 30, 2026K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16
Philips Medical Systems Nederland B.V., NL
MOS
Jul 30, 2026K262239Obsidian® Press Over Zirconia
Prismatik Dentalcraft, Inc.
EIH
Jul 30, 2026K261835LOGIQ Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN