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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
MEL 90 Excimer Laser

Carl Zeiss Meditec AG

Cleared 2026-07-01

Registered with
  • US (FDA)
  • Canada (Health Canada)
LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460

Boston Scientific Corp

Cleared 2026-07-01

Registered with
  • US (FDA)
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 2026-07-01

Registered with
  • US (FDA)
OTS Hip

Ortoma AB

Cleared 2026-07-01

Registered with
  • US (FDA)
  • AU (TGA)
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy

SeaSpine Orthopedics Corporation

Cleared 2026-07-01

Registered with
  • US (FDA)
EasyWhip Family

Winter Innovations, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
Trevo Trak 21 Microcatheter

STRYKER NEUROVASCULAR

Cleared 2026-07-01

Registered with
  • US (FDA)
  • Canada (Health Canada)
RibPlate System

Stryker Leibinger

Cleared 2026-07-01

Registered with
  • US (FDA)
Transcend Bulk Fill Flowable Composite

Ultradent Products, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
Dual Energy THERMOCOOL SMARTTOUCH SF™ System

Biosense Webster, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
PD-L1 IHC 28-8 pharmDx

Agilent Technologies, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Tetric plus Fill;Tetric plus Flow

Ivoclar Vivadent AG

Cleared 2026-07-01

Registered with
  • US (FDA)
Neodent Implant System - NeoConvert Fit

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Cleared 2026-07-01

Registered with
  • US (FDA)
Bulkamid Urethral Bulking System

Boston Scientific Corp

Cleared 2026-07-01

Registered with
  • US (FDA)
CHROMIX

Termosalud, S.L.

Cleared 2026-07-01

Registered with
  • US (FDA)
  • EU (EUDAMED)
OSSTM Orthopedic Salvage System

Biomet, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
Enteral Syringe (20ml, 60ml)

CHIRANA T.Injecta, a.s.

Cleared 2026-07-01

Registered with
  • US (FDA)
ProVee System for BPH

Proverum Limited

Cleared 2026-07-01

Registered with
  • US (FDA)
ISAAC Neurovascular Navigation Catheter

MicroVention, Inc., d/b/a Terumo Neuro

Cleared 2026-06-30

Registered with
  • US (FDA)
UB ERP System

Universal Brain

Cleared 2026-06-30

Registered with
  • US (FDA)
NorthStar Mapping System (MAP01 or MAP01-01)

Imricor Medical Systems, Inc.

Cleared 2026-06-30

Registered with
  • US (FDA)
VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)

Biosense Webster, Inc.

Cleared 2026-06-30

Registered with
  • US (FDA)
PulseSelect PFA Loop Catheter

Medtronic, Inc

Cleared 2026-06-30

Registered with
  • US (FDA)
Dandy Ceramic Stain and Glaze

Zima International Inc dba Dandy

Cleared 2026-06-30

Registered with
  • US (FDA)
Ceribell Monitor

Ceribell, Inc.

Cleared 2026-06-30

Registered with
  • US (FDA)
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Serpex Medical, Inc.

Cleared 2026-06-30

Registered with
  • US (FDA)
MeVis AVM Contour

Mevis Medical Solutions AG

Cleared 2026-06-30

Registered with
  • US (FDA)
Omnipod 6 algorithm

Insulet Corp.

Cleared 2026-06-29

Registered with
  • US (FDA)
Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)

STERILMED, INC.

Cleared 2026-06-29

Registered with
  • US (FDA)
Irrigation Tubing Bipolar Cord Set

NEW DEANTRONICS TAIWAN LTD.

Cleared 2026-06-29

Registered with
  • US (FDA)
Injectable Root Canal Sealer (KP-Root SP)

Guilin Kevin Peter Technology Co Ltd

Cleared 2026-06-29

Registered with
  • US (FDA)
CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA), and RECAP Viewer

Saluda Medical Pty. , Ltd.

Cleared 2026-06-29

Registered with
  • US (FDA)
Zolid Lunaris

Amann Girrbach AG

Cleared 2026-06-29

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

CYNOSURE LUTRONIC TECHNOLOGY CORPORATION

Cleared 2026-06-29

Registered with
  • US (FDA)
  • Canada (Health Canada)
ADAS 3D

Adas3D Medical S.L.

Cleared 2026-06-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Agada Medical, Ltd.

Cleared 2026-06-29

Registered with
  • US (FDA)
Pangea Femur Reconstruction System

Stryker Corp.

Cleared 2026-06-29

Registered with
  • US (FDA)
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)

GUANGDONG NEWDERMO BIOTECH CO., LTD

Cleared 2026-06-29

Registered with
  • US (FDA)
Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary IVL Catheter

Shockwave Medical., Inc.

Cleared 2026-06-29

Registered with
  • US (FDA)
SOMNUM (SOMNUM)

Honeynaps Co,. , Ltd.

Cleared 2026-06-27

Registered with
  • US (FDA)
MIST IC

Imagine Milling Technologies, LLC

Cleared 2026-06-27

Registered with
  • US (FDA)
BraiN20® (BraiN20)

Time IS Brain, S.L.

Cleared 2026-06-27

Registered with
  • US (FDA)
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline

Merz North America, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
  • AU (TGA)
Tendril STS Leads; Ultipace Leads; Optisense Leads

Abbott Medical

Cleared 2026-06-26

Registered with
  • US (FDA)
BioTracker 2.0

Biotracker, LLC

Cleared 2026-06-26

Registered with
  • US (FDA)
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)

Ziree Co., Ltd.

Cleared 2026-06-26

Registered with
  • US (FDA)
Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

Cadwell Industries, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)

Edwards Lifesciences, LLC

Cleared 2026-06-26

Registered with
  • US (FDA)
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

Shenzhen Changkun Technology Co., Ltd.

Cleared 2026-06-26

Registered with
  • US (FDA)
RADIESSE 1.3CC AND 0.3CC

Merz North America, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)