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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.

3,670 devices · when each source was last refreshed

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

Device
Juveena Hydrogel System

Rejoni, Inc.

Cleared 2026-09-28

Registered with
  • US (FDA)
Cochlear Auditory Brainstem Implant System

Cochlear Americas

Cleared 2026-09-28

Registered with
  • US (FDA)
ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

Kestra Medical Technologies, Inc.

Cleared 2026-09-28

Registered with
  • US (FDA)
LifePulse High Frequency Ventilator (LifePulse HFV) Model 204

Bunnell, Inc.

Cleared 2026-09-28

Registered with
  • US (FDA)
Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)

Fit-Pro KFT (Ltd.) - DBA E-Fit

Cleared 2026-09-27

Registered with
  • US (FDA)
Kentrospine Viktr-MIS® Pedicle screw system

Rivarp Medical Private Limited

Cleared 2026-09-27

Registered with
  • US (FDA)
Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-09-25

Registered with
  • US (FDA)
Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014)

Biotronik, GmbH & Co.

Cleared 2026-09-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
DistaSense(TM) (v1)

Life Detection Technologies

Cleared 2026-09-25

Registered with
  • US (FDA)
Liverty™ TIPS Stent Graft

Bard Peripheral Vascular Inc

Cleared 2026-09-25

Registered with
  • US (FDA)
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

HYUNDAI BIOLAND Co Ltd

Cleared 2026-09-25

Registered with
  • US (FDA)
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Tempus ECG-MR

Tempus AI, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Altis Full Face Mask

Respironics, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-09-25

Registered with
  • US (FDA)
Estemp Implant

Spident Co., Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6

Biotronik, GmbH & Co.

Cleared 2026-09-25

Registered with
  • US (FDA)
syngo.CT Brain Quantification

Siemens Medical Solutions USA, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Arthrex Beaming System

Arthrex, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
LCS TOTAL KNEE SYSTEM

Depuy, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

Solventum Us, LLC

Cleared 2026-09-25

Registered with
  • US (FDA)
FINEVISION HP Trifocal IOLs

Beaver-Visitec International Ltd

Cleared 2026-09-25

Registered with
  • US (FDA)
UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)

Karl Storz SE & CO.KG

Cleared 2026-09-25

Registered with
  • US (FDA)
Cordella Pulmonary Artery Sensor System (CorPASS)

Endotronix, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
TumorSight Risk

SimBioSys, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Invisalign System

Align Technology Ltd

Cleared 2026-09-25

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
CapsoView (CVV); CapsoCloud (CLD)

CapsoVision, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
S-Patch CardioAI

Wellysis Corp.

Cleared 2026-09-25

Registered with
  • US (FDA)
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges

Ezisurg Medical Co., Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
Xpert Respiratory Panel

Cepheid Inc

Cleared 2026-09-25

Registered with
  • US (FDA)
Aevice Wheeze Detection Module

Aevice Health Pte. , Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
Braun Aura 9 (6042)

Cyden Limited

Cleared 2026-09-25

Registered with
  • US (FDA)
AeroPace® System

Lungpacer Medical USA, Inc.

Cleared 2026-09-25

Registered with
  • US (FDA)
Profoject™ Safety Sliding Blood Collection Set

Cmt Health Pte., Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
Profoject™ LOR Syringe

Cmt Health Pte., Ltd.

Cleared 2026-09-25

Registered with
  • US (FDA)
ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER

Medtronic Cryocath, LP

Cleared 2026-09-25

Registered with
  • US (FDA)
MD-6000S Bladder Scanner

Meda Co Ltd

Cleared 2026-09-24

Registered with
  • US (FDA)
Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)

Shenzhen Nuon Medical Equipment Co., Ltd.

Cleared 2026-09-24

Registered with
  • US (FDA)
KARL STORZ SUPRALOOP

Karl Storz SE & CO.KG

Cleared 2026-09-24

Registered with
  • US (FDA)
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Medtronic, Inc

Cleared 2026-09-24

Registered with
  • US (FDA)
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Abbott Medical

Cleared 2026-09-24

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
OsseoFit Stemless Shoulder System

Zimmer Inc

Cleared 2026-09-24

Registered with
  • US (FDA)
Orsiro Mission larger diameter stents Ø 4.5 5.0 mm

Biotronik, GmbH & Co.

Cleared 2026-09-24

Registered with
  • US (FDA)
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus

DiaSorin, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
Align® Cover and Pad Guidance Tool

Civco Medical Instruments Co., Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
Electric Scooter (FNS01,FNS03)

Anhui Jbh Medical Apparatus Co., Ltd.

Cleared 2026-09-24

Registered with
  • US (FDA)
Cannula with Guide

AtriCure, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
PicoreMax (PicoreMax)

Bluecore Co., Ltd.

Cleared 2026-09-24

Registered with
  • US (FDA)
corra™ cervical plating system

Carlsmed, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)