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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.

3,708 devices · when each source was last refreshed

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

Device
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)
REGENT MECHANICAL HEART VALVE

Abbott Medical

Cleared 2026-06-11

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

Medacta International S.A.

Cleared 2026-06-10

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

Bard Peripheral Vascular 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)
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)
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)
COLOGUARD

Exact Sciences Corporation

Cleared 2026-06-09

Registered with
  • US (FDA)
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Materialise N.V

Cleared 2026-06-09

Registered with
  • US (FDA)
Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th

Medtronic, Inc

Cleared 2026-06-09

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
ChanPin Pedicle Screw Spinal System

Chanpin Medtak Co., Ltd.

Cleared 2026-06-09

Registered with
  • US (FDA)
Lipocosm Harmonic System

LIPOCOSM, LLC

Cleared 2026-06-08

Registered with
  • US (FDA)
2D HIP PLANNING SOFTWARE

ONE ORTHO

Cleared 2026-06-08

Registered with
  • US (FDA)
  • EU (EUDAMED)
ELEOS™ with NanoCept® Technology Limb Salvage System

Onkos Surgical, Inc

Cleared 2026-06-08

Registered with
  • US (FDA)
EchoNext

Pathwai, Inc.

Cleared 2026-06-08

Registered with
  • US (FDA)
Virgo Mobility Scooter (Virgo-D,Virgo-F)

Jiangsu Intco Medical Products Co., Ltd.

Cleared 2026-06-08

Registered with
  • US (FDA)
Apollo Quattro (APQ-10M)

Weero Co.

Cleared 2026-06-08

Registered with
  • US (FDA)
Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System

Dexcom, Inc.

Cleared 2026-06-08

Registered with
  • US (FDA)
OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-06-05

Registered with
  • US (FDA)
AbsorbaSeal 5.6.7F Vascular Closure Device

Cyndrx, LLC

Cleared 2026-06-05

Registered with
  • US (FDA)
FieldFlex Steerable Sheath

Centerpoint Systems

Cleared 2026-06-05

Registered with
  • US (FDA)
Occlutech Pistol Pusher

Occlutech Holding AG

Cleared 2026-06-05

Registered with
  • US (FDA)
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

Unimed Medical Supplies, Inc.

Cleared 2026-06-05

Registered with
  • US (FDA)
PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

Cordis US Corp

Cleared 2026-06-05

Registered with
  • US (FDA)
Digital C-ARM with 3D

Allengers Medical Systems Limited

Cleared 2026-06-05

Registered with
  • US (FDA)
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

Nextstep Arthopedix, LLC

Cleared 2026-06-05

Registered with
  • US (FDA)
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Edwards Lifesciences, LLC

Cleared 2026-06-05

Registered with
  • US (FDA)