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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
Tula Tympanostomy Tube Delivery Device

Tusker Medical

Cleared 2026-04-23

Registered with
  • US (FDA)
TruSight Oncology Comprehensive

Illumina, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
Introducer Sheath Set

Cardiocycle Medical(Suzhou) Co., Ltd.

Cleared 2026-04-23

Registered with
  • US (FDA)
Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
Freezor MAX 209F3,209F5

Medtronic Cryocath, LP

Cleared 2026-04-23

Registered with
  • US (FDA)
Mobility Scooter (X-12, X-14, X-17)

Wuyi Aichi Industry & Trade Co.,Ltd.

Cleared 2026-04-22

Registered with
  • US (FDA)
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)

Steritec Products, Inc.

Cleared 2026-04-22

Registered with
  • US (FDA)
uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-04-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

NOOANCE

Cleared 2026-04-22

Registered with
  • US (FDA)
VANISH PRO

Ddc Technologies, Inc.

Cleared 2026-04-22

Registered with
  • US (FDA)
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd.

Cleared 2026-04-22

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

Carlsmed, Inc.

Cleared 2026-04-22

Registered with
  • US (FDA)
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

Erbe Elektromedizin GmbH

Cleared 2026-04-22

Registered with
  • US (FDA)
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

Otto Bock Healthcare Products GmbH

Cleared 2026-04-22

Registered with
  • US (FDA)
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)

Jiangxi Aov Maternity & Baby Products Co., Ltd.

Cleared 2026-04-22

Registered with
  • US (FDA)
SIENTRA SILICONE GEL BREAST IMPLANTS

TIGER AESTHETICS MEDICAL, LLC

Cleared 2026-04-22

Registered with
  • US (FDA)
IMMULITE 2000 Free PSA

Siemens Medical Solutions Diagnostics

Cleared 2026-04-21

Registered with
  • US (FDA)
Korotkoff sound blood pressure monitor

Beijing Hanvon Health Technology Co., Ltd.

Cleared 2026-04-21

Registered with
  • US (FDA)
CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-04-21

Registered with
  • US (FDA)
EvoEndo Single-Use Endoscopy System

EvoEndo, Inc.

Cleared 2026-04-21

Registered with
  • US (FDA)
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)

SHENZHEN SEMLAMP INTELLIGENT TECHNOLOGY CO., LTD.

Cleared 2026-04-21

Registered with
  • US (FDA)
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

bioMérieux SA

Cleared 2026-04-21

Registered with
  • US (FDA)
IMMULITE 2000 PSA

Siemens Healthcare Diagnostics

Cleared 2026-04-21

Registered with
  • US (FDA)
Neuspera Sacral Neuromodulation (SNM) System

Neuspera Medical, Inc.

Cleared 2026-04-21

Registered with
  • US (FDA)
IMMULITE 2000 AFP

Siemens Healthcare Diagnostics

Cleared 2026-04-21

Registered with
  • US (FDA)
RhythmStar System (SL)

Rhythmedix, LLC

Cleared 2026-04-21

Registered with
  • US (FDA)
BosCATH Support Catheter

Sonorous NV, Inc.

Cleared 2026-04-21

Registered with
  • US (FDA)
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Tigon Medical

Cleared 2026-04-21

Registered with
  • US (FDA)
FOLLISCAN

MIM Fertility Sp. z o.o.

Cleared 2026-04-20

Registered with
  • US (FDA)
  • EU (EUDAMED)
xStep (xStep)

Spinex, Inc.

Cleared 2026-04-20

Registered with
  • US (FDA)
SAGI Cervical Cage System

ZheJiang Decans Medical Devices Co., Ltd.

Cleared 2026-04-20

Registered with
  • US (FDA)
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

Hubei Xinxin Non-woven Co,Ltd

Cleared 2026-04-20

Registered with
  • US (FDA)
Power Wheelchair (N5919 series)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Cleared 2026-04-20

Registered with
  • US (FDA)
Luminoah FLOW™ Enteral Nutrition System

Luminoah

Cleared 2026-04-20

Registered with
  • US (FDA)
Lunar Astra

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-04-20

Registered with
  • US (FDA)
Thoraflex™ Hybrid

Vascutek, Ltd.

Cleared 2026-04-20

Registered with
  • US (FDA)
  • UK (MHRA)
EnSite X EP System

Abbott Medical

Cleared 2026-04-20

Registered with
  • US (FDA)
Q-Switched Nd: YAG Laser System (Glamor Q)

Nanjing Bestview Laser S&T Co., Ltd.

Cleared 2026-04-20

Registered with
  • US (FDA)
SmartSurgN Visualization System

Smartsurgn Incorporated

Cleared 2026-04-20

Registered with
  • US (FDA)
Edwards eSheath+ introducer set

Edwards Lifesciences, LLC

Cleared 2026-04-17

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
StarClose SE™ Vascular Closure System

Abbott Vascular Devices

Cleared 2026-04-17

Registered with
  • US (FDA)
MTS Gepotidacin 0.016-256 µg/mL

Liofilchem S. R. L.

Cleared 2026-04-17

Registered with
  • US (FDA)
Dura-Arch

Hangzhou Shining3D Dental Technology Co., Ltd.

Cleared 2026-04-17

Registered with
  • US (FDA)
QDOT MICRO Uni-Directional Navigation Catheter

Biosense Webster, Inc.

Cleared 2026-04-17

Registered with
  • US (FDA)
DYNEX® External Fixation Systems

Vilex, Inc.

Cleared 2026-04-17

Registered with
  • US (FDA)
Novasight Hybrid System

CONAVI MEDICAL INC.

Cleared 2026-04-17

Registered with
  • US (FDA)
Wovyn Depth Electrode

Sensomedical Labs, Ltd.

Cleared 2026-04-17

Registered with
  • US (FDA)
Neonav ECG Tip Location System

Navi Medical Technologies

Cleared 2026-04-17

Registered with
  • US (FDA)
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

CHIRANA T.Injecta, a.s.

Cleared 2026-04-17

Registered with
  • US (FDA)
VENASEAL CLOSURE SYSTEM

Medtronic Vascular

Cleared 2026-04-17

Registered with
  • US (FDA)