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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.

3,689 devices · when each source was last refreshed

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

Device
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)

Impedimed Pty , Ltd.

Cleared 2026-01-28

Registered with
  • US (FDA)
Aevumed PROTEKT Suture Anchor

Aevumed, Inc.

Cleared 2026-01-28

Registered with
  • US (FDA)
XeliteMed SuperM-Fix Spinal Bone Cement

Xelite Biomed , Ltd.

Cleared 2026-01-28

Registered with
  • US (FDA)
Sterilization Pouch/Roll

STERIVIC MEDICAL CO.,LTD

Cleared 2026-01-28

Registered with
  • US (FDA)
Vena MicroAngioscope™ System

Vena Medical Holdings Corp

Cleared 2026-01-28

Registered with
  • US (FDA)
Sleepiz One+ (Model 2.5)

Sleepiz AG

Cleared 2026-01-28

Registered with
  • US (FDA)
HIGHERDOSE Body Sculptor (Model: GS-03)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-01-28

Registered with
  • US (FDA)
Mpact 3D Metal Implants Extension – DMLS Technology

Medacta International S.A.

Cleared 2026-01-28

Registered with
  • US (FDA)
NorthStar Mapping System

Imricor Medical Systems, Inc.

Cleared 2026-01-28

Registered with
  • US (FDA)
  • EU (EUDAMED)
Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd.

Cleared 2026-01-28

Registered with
  • US (FDA)
GBT Machine AIRFLOW Prophylaxis Master

E.M.S Electro Medical Systems S.A

Cleared 2026-01-28

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
InbellaIgnite RF System

Inbella Medical, Inc.

Cleared 2026-01-27

Registered with
  • US (FDA)
Optima Coil System (OptiOne Coil System)

Balt USA, LLC

Cleared 2026-01-27

Registered with
  • US (FDA)
Access anti-HAV IgM

Beckman Coulter, Inc.

Cleared 2026-01-27

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Reusable 3 Button Fingerswitch Wand

Soniquence LLC

Cleared 2026-01-27

Registered with
  • US (FDA)
FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Boston Scientific Corp

Cleared 2026-01-27

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
MAC 7 Resting ECG Analysis System

GE Medical Systems Information Technologies, Inc

Cleared 2026-01-26

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Ascent3T Neonatal Magnetic Resonance Imaging System

Eyas Medical Imaging, Inc.

Cleared 2026-01-26

Registered with
  • US (FDA)
Tablo Hemodialysis System (PN-0008000, PN-0006000U)

Outset Medical

Cleared 2026-01-26

Registered with
  • US (FDA)
Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda

Cleared 2026-01-24

Registered with
  • US (FDA)
Holmium Laser Therapeutic Apparatus (HZ-40)

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Cleared 2026-01-24

Registered with
  • US (FDA)
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-01-23

Registered with
  • US (FDA)
Elitone for Men

Elidah, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Life Spine, LLC

Cleared 2026-01-23

Registered with
  • US (FDA)
3.0T AIR 32CH HNA

Ge Healthcare Coils (Usa Instruments, Inc.)

Cleared 2026-01-23

Registered with
  • US (FDA)
BodyGuardian Remote Monitoring System (BGRMS v3.0)

BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

Cleared 2026-01-23

Registered with
  • US (FDA)
Pneumo Dissector Hook

ab medica sas

Cleared 2026-01-23

Registered with
  • US (FDA)
Syntex Exam Gloves

Basic Medical Technology, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
AccuContour 4.0

Manteia Technologies Co., Ltd.

Cleared 2026-01-23

Registered with
  • US (FDA)
Evidence MultiSTAT DOA Urine MultiPlex

Randox Laboratories Limited

Cleared 2026-01-23

Registered with
  • US (FDA)
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

SHENZHEN RAINBOW TECHNOLOGY CO., LTD.

Cleared 2026-01-23

Registered with
  • US (FDA)
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Point Robotics MedTech, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
New Day Skin Spray

Silk Holdings, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

Devicor Medical Products, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
Perin Health System (PHD80060-2)

Perin Health Devices, LLC

Cleared 2026-01-22

Registered with
  • US (FDA)
AV Vascular

Philips Medical Systems Nederland BV

Cleared 2026-01-22

Registered with
  • US (FDA)
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

Lima Corporate S.P.A.

Cleared 2026-01-22

Registered with
  • US (FDA)
Pump In Style® Pro+

Medela, Inc.

Cleared 2026-01-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
AI-Rad Companion Brain MR

Siemens Healthcare GmbH

Cleared 2026-01-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Straumann Variobase Abutments XC for Bridge/Bar

Institut Straumann AG

Cleared 2026-01-22

Registered with
  • US (FDA)
Genie MAX Large Bore Introducer Sheath

Cultiv8 1, LLC

Cleared 2026-01-22

Registered with
  • US (FDA)
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Astura Medical

Cleared 2026-01-22

Registered with
  • US (FDA)
Device 104 Particulate

Geistlich-Pharma

Cleared 2026-01-22

Registered with
  • US (FDA)
PhenoMATRIX

Copan WASP Srl

Cleared 2026-01-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Getinge GSS67N Series Steam Sterilizer

Maquet GmbH (A Getinge Group Company)

Cleared 2026-01-22

Registered with
  • US (FDA)
IPDmilled Blanks

Implant Protesis Dental 2004, S.L.

Cleared 2026-01-22

Registered with
  • US (FDA)
Arthrex Variable Angle (VA) Proximal Tibia Plating System

Arthrex, Inc.

Cleared 2026-01-21

Registered with
  • US (FDA)
Boston Pico755

Boston Aesthetics, Inc.

Cleared 2026-01-21

Registered with
  • US (FDA)
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

Merit Medical Ireland, Ltd.

Cleared 2026-01-21

Registered with
  • US (FDA)
INFINITY™ OCT System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-01-21

Registered with
  • US (FDA)