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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
WRAPSODY® Cell-Impermeable Endoprosthesis

Merit Medical Systems, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Rosetta SM, Rosetta SP

Hass Corp.

Cleared 2026-06-11

Registered with
  • US (FDA)
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Synthes USA Products, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System

Biotronik, GmbH & Co.

Cleared 2026-06-11

Registered with
  • US (FDA)
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)

FloShield, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Dexter L6 System

Distalmotion SA

Cleared 2026-06-11

Registered with
  • US (FDA)
Verge™ Microcatheter

Instylla, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADVDD01, SED01, SEDR01, SES01); Adapta, Versa, Sensia IPG (SE

Medtronic, Inc

Cleared 2026-06-11

Registered with
  • US (FDA)
ICON 35; ICON 45; ICON 60; ICON 30FAF

Rehasense USA, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Dental X-ray System

Changzhou Boen Zhongding Medical Technology Co Ltd

Cleared 2026-06-11

Registered with
  • US (FDA)
Anura Mobile Core SDK (M1)

Nuralogix Corporation

Cleared 2026-06-11

Registered with
  • US (FDA)
AViTA Breast Pump

Avita Corporation

Cleared 2026-06-11

Registered with
  • US (FDA)
Fluoride Varnish (Type A,Type C)

Nagy Oral Technology Qinhuangdao Co., Ltd.

Cleared 2026-06-11

Registered with
  • US (FDA)
PROBEAT-CR

Hitachi High-Tech Corporation

Cleared 2026-06-11

Registered with
  • US (FDA)
Ion-L

SurGenTec, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
Masters Series™ Aortic Valved Graft with Hemashield™ Graft Technology (CAVGJ)

Abbott Medical

Cleared 2026-06-11

Registered with
  • US (FDA)
Respiration Rate algorithm

Edwards Lifesciences, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
i-STAT hs-TnI cartridge with the i-STAT Alinity System

Abbott Point of Care, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
SKINVIVE by JUVEDERM®

ALLERGAN

Cleared 2026-06-11

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
"Tech-Image" Video Endoscope System

Tech-Image CO., LTD.

Cleared 2026-06-10

Registered with
  • US (FDA)
Profoject™ Safety Pen Needles

Cmt Health Pte., Ltd.

Cleared 2026-06-10

Registered with
  • US (FDA)
Cryo And Thermo Therapy System

Xiamen Weiyou Intelligent Technology Co.,Ltd

Cleared 2026-06-10

Registered with
  • US (FDA)
HeartMate II Left Ventricular Assist System (LVAS)

Abbott Medical

Cleared 2026-06-10

Registered with
  • US (FDA)
RxSight Insertion Device

Rxsight, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
  • AU (TGA)
Venovo Venous Stent System

Bard Peripheral Vascular Inc

Cleared 2026-06-10

Registered with
  • US (FDA)
Tinnitus Therapy

Sivantos GmbH

Cleared 2026-06-10

Registered with
  • US (FDA)
LARS ACJ

Movmedix

Cleared 2026-06-10

Registered with
  • US (FDA)
Colli-Pee•Dx Urine Collection Kit

DNA Genotek, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
Bard™ Fluency™ Plus Endovascular Stent Graft

Bard Peripheral Vascular Inc

Cleared 2026-06-10

Registered with
  • US (FDA)
  • Canada (Health Canada)
MSS - Humeral reverse liners extension

Medacta International S.A.

Cleared 2026-06-10

Registered with
  • US (FDA)
MediBeacon® Transdermal GFR Measurement System (GFR)

Medibeacon, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P

Carl Zeiss Meditec Production, LLC

Cleared 2026-06-10

Registered with
  • US (FDA)
Guardant360 CDx

Guardant Health, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
  • UK (MHRA)
LifeStent™ 5F Vascular Stent Systems

Bard Peripheral Vascular Inc

Cleared 2026-06-10

Registered with
  • US (FDA)
THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS

Biosense Webster, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

Centerline Biomedical, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
HeartMate 3™ Left Ventricular Assist System (LVAS)

Abbott Medical

Cleared 2026-06-10

Registered with
  • US (FDA)
Anteralign LS coverplate

Tyber Medical, LLC

Cleared 2026-06-10

Registered with
  • US (FDA)
Penumbra System (Thunderbolt Aspiration Tubing)

Penumbra, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
Covera™ Vascular Covered Stent

C.R. Bard, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
DeepXray Spina

Alpha Intelligence Manifolds, Inc.

Cleared 2026-06-10

Registered with
  • US (FDA)
BOBBY Balloon Guide Catheter

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

Cleared 2026-06-09

Registered with
  • US (FDA)
LAP-iX2N

Sejong Medical Co., Ltd.

Cleared 2026-06-09

Registered with
  • US (FDA)
Mother's Nature W1 Warming Wearable Breast Pump

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-06-09

Registered with
  • US (FDA)
TekBrace Solo Soft Tissue Reinforcement Device

Theramicro

Cleared 2026-06-09

Registered with
  • US (FDA)
RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual

Boston Scientific Corp

Cleared 2026-06-09

Registered with
  • US (FDA)
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

Hathor Professional Skincare , Ltd.

Cleared 2026-06-09

Registered with
  • US (FDA)
ES-Series

E-Scopics

Cleared 2026-06-09

Registered with
  • US (FDA)
DESS Dental Smart Solutions

Terrats Medical SL

Cleared 2026-06-09

Registered with
  • US (FDA)
ERBECRYO 2 Cryosurgical Unit and Accessories

Erbe Elektromedizin GmbH

Cleared 2026-06-09

Registered with
  • US (FDA)