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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.

3,665 devices · when each source was last refreshed

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

Device
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation

Cleared 2026-01-20

Registered with
  • US (FDA)
Baylis Connector Cable

BAYLIS MEDICAL TECHNOLOGIES INC.

Cleared 2026-01-18

Registered with
  • US (FDA)
  • Canada (Health Canada)
CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Biosense Webster, Inc.

Cleared 2026-01-18

Registered with
  • US (FDA)
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Medtronic, Ireland

Cleared 2026-01-17

Registered with
  • US (FDA)
NeuroSpan Bridge

Auxilium Biotechnologies, Inc.

Cleared 2026-01-17

Registered with
  • US (FDA)
Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

Medtronic, Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
Xpert GI Panel

Cepheid Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
  • UK (MHRA)
Imagine® Enterprise Suite

Softlink International, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
FL-10000U Respiratory Humidifier

Flexicare Medical Ltd

Cleared 2026-01-16

Registered with
  • US (FDA)
VITAL Tubing Sets for Hemodialysis

Vital Healthcare Sdn Bhd

Cleared 2026-01-16

Registered with
  • US (FDA)
CoolTone

Zimmer Medizinsysteme GmbH

Cleared 2026-01-16

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Hycor Biomedical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
Eyer 2

Phelcom Technologies

Cleared 2026-01-16

Registered with
  • US (FDA)
Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

Curiteva, LLC

Cleared 2026-01-16

Registered with
  • US (FDA)
SOLIUS PRO UVB Light Panel

Solius Labs, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
actiTENS mini

SUBLIMED

Cleared 2026-01-16

Registered with
  • US (FDA)
  • EU (EUDAMED)
MY01 Continuous Compartmental Pressure Monitor

MY01, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Azurion R3.1

Philips Medical Systems, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

Intuitive Surgical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
SeptAlign

Spirair, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
LZI Buprenorphine II Enzyme Immunoassay

Lin-Zhi International Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
qXR-Detect

Qure.Ai Technologies

Cleared 2026-01-16

Registered with
  • US (FDA)
Natrelle 133S Tissue Expanders

AbbVie, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
Tru Hematology Test

Truvian Sciences, 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, IMPLANT AND SIZING TOOL

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)
OVATIO CRT & SITUS OTW LV

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)
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)
Ignite RF System

Inmode , Ltd.

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)
BIOGRAPH One

Siemens Healthineers AG

Cleared 2026-01-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
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)
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)
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Maxx Orthopedics, Inc.

Cleared 2026-01-15

Registered with
  • US (FDA)