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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.

3,400 devices · when each source was last refreshed

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

Device
Tru Hematology Test

Truvian Sciences, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
NexGen® LPS-Flex / LPS Mobile Bearing Knee System

Zimmer Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
Sana Device

Sana Health

Cleared 2026-01-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
OptoMonitor 3

Opsens, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
WAVE Clinical Platform (2.0.000)

Baxter Healthcare Corp/ Excel Medical

Cleared 2026-01-16

Registered with
  • US (FDA)
LINX REFLUX MANAGEMENT SYSTEM

Torax Medical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
  • AU (TGA)
Toro 88 Superbore Catheter

Toro Neurovascular, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
Ion-C

SurGenTec, LLC

Cleared 2026-01-16

Registered with
  • US (FDA)
da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

Medtronic Minimed

Cleared 2026-01-15

Registered with
  • US (FDA)
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

Elekta Solutions AB

Cleared 2026-01-15

Registered with
  • US (FDA)
Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

Shanghai Bangbang Robotics Co, Ltd

Cleared 2026-01-15

Registered with
  • US (FDA)
Diagnocat

Dgnct, LLC

Cleared 2026-01-15

Registered with
  • US (FDA)
  • AU (TGA)
Electric Wheelchair (DH01168)

Foshan Dahao Medical Technology Co., Ltd.

Cleared 2026-01-15

Registered with
  • US (FDA)
ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS

Microport Crm, USA, Inc.

Cleared 2026-01-15

Registered with
  • US (FDA)
Nano-Check Influenza A+B Test

Nano-Ditech Co.

Cleared 2026-01-15

Registered with
  • US (FDA)
GYNECARE INTERCEED™ Absorbable Adhesion Barrier

ETHICON LLC

Cleared 2026-01-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)

Trimed Pvt Ltd

Cleared 2026-01-15

Registered with
  • US (FDA)
Livewire™ TC XLS™

St. Jude Medical, Inc.

Cleared 2026-01-15

Registered with
  • US (FDA)
Ignite RF System

Inmode , Ltd.

Cleared 2026-01-15

Registered with
  • US (FDA)
SURGICEL® Absorbable Hemostats

ETHICON LLC

Cleared 2026-01-15

Registered with
  • US (FDA)
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Sleepnet Corporation

Cleared 2026-01-15

Registered with
  • US (FDA)
AltiVate Reverse® ADLC Glenosphere

Encore Medical LP

Cleared 2026-01-15

Registered with
  • US (FDA)
SDS Growing Rod

BAAT Medical Products B.V.

Cleared 2026-01-15

Registered with
  • US (FDA)
N22 EZ Glenosphere

Shoulder Innovations, LLC

Cleared 2026-01-15

Registered with
  • US (FDA)
Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc

Cleared 2026-01-15

Registered with
  • US (FDA)
  • AU (TGA)
Curiteva Porous PEEK Cervical Interbody Fusion System

Curiteva, LLC

Cleared 2026-01-15

Registered with
  • US (FDA)
Aventus Thrombectomy System

Inquis Medical

Cleared 2026-01-15

Registered with
  • US (FDA)
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Thera B Medical Products

Cleared 2026-01-15

Registered with
  • US (FDA)
prodisc® C

Centinel Spine

Cleared 2026-01-15

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Safire™ TX Bi-directional and Therapy™ Dual-8™

Irvine Biomedical,Inc.(Ibi)

Cleared 2026-01-15

Registered with
  • US (FDA)
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Maxx Orthopedics, Inc.

Cleared 2026-01-15

Registered with
  • US (FDA)
Esperance pHLO Aspiration System

phenox GmbH

Cleared 2026-01-15

Registered with
  • US (FDA)
VitaSmart Hypothermic Oxygenated Perfusion System

Bridge TO Life, Ltd.

Cleared 2026-01-15

Registered with
  • US (FDA)
BIOGRAPH One

Siemens Healthineers

Cleared 2026-01-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Cervical Interbody and VBR Fusion System

Sync Surgical

Cleared 2026-01-14

Registered with
  • US (FDA)
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

Philips Medical Systems Nederland BV

Cleared 2026-01-14

Registered with
  • US (FDA)
LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Advanced Medical Solutions Ltd

Cleared 2026-01-14

Registered with
  • US (FDA)
Laboratorios Biogalenic Sterile Water for Inhalation, USP

Laboratorios Biogalenic S.A. DE C.V.

Cleared 2026-01-14

Registered with
  • US (FDA)
Orthoscan TAU MVP Mini C-Arm System

Ziehm-Orthoscan, Inc

Cleared 2026-01-14

Registered with
  • US (FDA)
Meticuly Patient-Specific Titanium Mesh Implant

Meticuly Co., Ltd.

Cleared 2026-01-14

Registered with
  • US (FDA)
  • UK (MHRA)
Cardinal Health Nitrile Examination Gloves Extended Cuff

Cardinalhealth

Cleared 2026-01-14

Registered with
  • US (FDA)
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Brainlab SE

Cleared 2026-01-14

Registered with
  • US (FDA)
Concerto Versa™ Detachable Coil

Medtronic, Inc

Cleared 2026-01-14

Registered with
  • US (FDA)
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

Kossan International Sdn Bhd

Cleared 2026-01-13

Registered with
  • US (FDA)
Bright Cavity Liner

DMP Dental Industry SA

Cleared 2026-01-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Stryker Endoscopy

Cleared 2026-01-13

Registered with
  • US (FDA)
BEAR® (Bridge-Enhanced ACL Restoration) Implant

Miach Orthopaedics, Inc.

Cleared 2026-01-13

Registered with
  • US (FDA)
Swedge™ Pedicle Screw Fixation System Bezier Rod

Spinal Resources, Inc.

Cleared 2026-01-13

Registered with
  • US (FDA)
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Spectrum Dynamics Medical, Ltd.

Cleared 2026-01-13

Registered with
  • US (FDA)