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Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,716 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Sleep Apnea Feature (v2.0)

Samsung Electronics Co., Ltd.

Cleared 2026-07-20

Registered with
  • US (FDA)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

Hartalega NGC Sdn. Bhd.

Cleared 2026-07-20

Registered with
  • US (FDA)
ENDOSCOPE HOLDER (182214)

AKTORmed GmbH

Cleared 2026-07-20

Registered with
  • US (FDA)
Hi-D Imaging 4TAVR

Hi-D Imaging AG

Cleared 2026-07-20

Registered with
  • US (FDA)
Dental Zirconia Blank & Coloring Liquid

Hunan Qinghao Puzhong Technology Co., Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
ZEISS CLINIC 360

Carl Zeiss Meditec AG

Cleared 2026-07-17

Registered with
  • US (FDA)
  • Canada (Health Canada)
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM

Stryker Spine, LLC

Cleared 2026-07-17

Registered with
  • US (FDA)
Natural Cycles

Natural Cycles Nordic AB

Cleared 2026-07-17

Registered with
  • US (FDA)
LED LCD Monitor (OEV-271H)

Lg Electronics

Cleared 2026-07-17

Registered with
  • US (FDA)
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Biofire Defense, LLC

Cleared 2026-07-17

Registered with
  • US (FDA)
SportSuite Vision Software

Stryker Endoscopy

Cleared 2026-07-17

Registered with
  • US (FDA)
Catalyft PL Expandable Interbody System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-07-17

Registered with
  • US (FDA)
Drivewire 35 Guidewire

Rapid-Medical , Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
Cubresa BrainPET

Cubresa, Inc.

Cleared 2026-07-17

Registered with
  • US (FDA)
Virasight

Virasoft Corporation

Cleared 2026-07-17

Registered with
  • US (FDA)
Diode laser hair removal machine (QDTM-04)

Beijing Nubway S&T Co., Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

Assure Tech. Co., Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
LoFric Origo Pro Coudé

Wellspect AB

Cleared 2026-07-17

Registered with
  • US (FDA)
CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

Shenzhen Chuanghong Zhilian Technology Co., Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )

Trimed Pvt Ltd

Cleared 2026-07-16

Registered with
  • US (FDA)
Misago RX Self-expanding Peripheral Stent

Terumo Medical Corp.

Cleared 2026-07-16

Registered with
  • US (FDA)
Endomat Select (UP220)

Karl Storz SE & CO.KG

Cleared 2026-07-16

Registered with
  • US (FDA)
Socrates Aspiration System (Socrates 70 Aspiration Catheter)

Scientia Vascular, LLC

Cleared 2026-07-16

Registered with
  • US (FDA)
Palisades™ Buttress Plate System

Bethesda Medical Devices

Cleared 2026-07-16

Registered with
  • US (FDA)
cobas® BV/CV

Roche Molecular Systems, Inc.

Cleared 2026-07-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Cable Ready Cable Grip System

Pioneer Surgical Technology

Cleared 2026-07-16

Registered with
  • US (FDA)
  • EU (EUDAMED)
Skin Air Cooling System (QALF-01)

Beijing Nubway S&T Co., Ltd.

Cleared 2026-07-16

Registered with
  • US (FDA)
PRISMAFLEX TPE2000 SET

VANTIVE US HEALTHCARE LLC

Cleared 2026-07-15

Registered with
  • US (FDA)
Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant

Stryker Leibinger

Cleared 2026-07-15

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant

Atlas Spine, LLC

Cleared 2026-07-15

Registered with
  • US (FDA)
SkeletonPlanner

UPlanner B.V. - Presurgeo

Cleared 2026-07-15

Registered with
  • US (FDA)
TorEx Lung Perfusion System

TRAFEROX TECHNOLOGIES INC.

Cleared 2026-07-15

Registered with
  • US (FDA)
  • Canada (Health Canada)
BIOGLUE SURGICAL ADHESIVE

Cryolife, Inc.

Cleared 2026-07-15

Registered with
  • US (FDA)
Profoject™ Pen Needles (Model A; Model B)

Cmt Health Pte., Ltd.

Cleared 2026-07-15

Registered with
  • US (FDA)
Aventus Thrombectomy System

Inquis Medical

Cleared 2026-07-15

Registered with
  • US (FDA)
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)

Dongguan Miqiang Technology Co Ltd

Cleared 2026-07-15

Registered with
  • US (FDA)
ThinkSono Guidance

ThinkSono Ltd

Cleared 2026-07-15

Registered with
  • US (FDA)
  • UK (MHRA)
Avitene Microfibrillar Collagen Hemostat (MCH) Flour; Avitene Microfibrillar Collagen Hemostat (MCH) UltraFoam; Avitene

Davol Inc., Sub. C. R. Bard, Inc.

Cleared 2026-07-15

Registered with
  • US (FDA)
Arista AH; Arista AH Absorbable Hemostat

Davol, Inc.

Cleared 2026-07-15

Registered with
  • US (FDA)
Better Diagnostics Dental Assist (BDDA) Version 1.0

Better Diagnostics AI Corp

Cleared 2026-07-15

Registered with
  • US (FDA)
NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system

Hamamatsu Photonics K.K.

Cleared 2026-07-15

Registered with
  • US (FDA)
WRAP System

Huneo, LLC

Cleared 2026-07-15

Registered with
  • US (FDA)
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

Kyocera Medical Technologies, Inc.

Cleared 2026-07-15

Registered with
  • US (FDA)
Universal Seal (5-12 mm)

Intuitive Surgical, Inc.

Cleared 2026-07-14

Registered with
  • US (FDA)
Symmetrix™ L Spinal System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-07-14

Registered with
  • US (FDA)
IC-8 Apthera Intraocular Lens (IOL)

Acu Focus, Inc.

Cleared 2026-07-14

Registered with
  • US (FDA)
IERO Mobility Scooter (IERO-01)

Jochu Technology Co., Ltd.

Cleared 2026-07-14

Registered with
  • US (FDA)
LIXI (LXOSFM1)

Luwi, LLC

Cleared 2026-07-14

Registered with
  • US (FDA)
Flow FL-100

Flow Neuroscience AB

Cleared 2026-07-14

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

Ambu AS

Cleared 2026-07-14

Registered with
  • US (FDA)