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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
SKIA-Head (Model: SKIA-ST00)

Skia, Inc.

Cleared 2026-02-23

Registered with
  • US (FDA)
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

Argon Medical Devices, Inc.

Cleared 2026-02-23

Registered with
  • US (FDA)
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

Philips Medical Systems Nederland BV

Cleared 2026-02-23

Registered with
  • US (FDA)
Mariana Minerva; Mariana Nimbus

ResMed PTY Ltd

Cleared 2026-02-23

Registered with
  • US (FDA)
Mobility Scooter (CL-Q3, CL-Q4)

Zhejiang Wei Ling New Energy Technology Co., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
IPL Hair Removal Device (Models: T31A, T32A)

SHENZHEN MLAY INTELLIGENT TECHNOLOGY CO., LTD.

Cleared 2026-02-23

Registered with
  • US (FDA)
YUWELL® Electronic Blood Pressure Monitor (YE650AR)

Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
Single Use Distal Cover MAJ-2315 (MAJ-2315)

Olympus Medical Systems Corporation

Cleared 2026-02-22

Registered with
  • US (FDA)
Advanced Tissue Resection Device

Micro-Tech (Nanjing) Co., Ltd .

Cleared 2026-02-21

Registered with
  • US (FDA)
KLS Martin Pure Pectus System

KLS Martin SE & Co KG

Cleared 2026-02-20

Registered with
  • US (FDA)
Disposable Ureteral Stents

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Cleared 2026-02-20

Registered with
  • US (FDA)
"POINT" Kinguide Agile Hybrid Navigation System; DRF Accessories Set

Point Robotics MedTech, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
QSCHECK UISACR

Qstag, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

Foreo, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
CARTO™ 3 EP Navigation System V8.4

Biosense Webster, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
SPRY TMS Therapy System (0550)

Soterix Medical, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
KLS Martin Ixos System

KLS Martin SE & Co KG

Cleared 2026-02-20

Registered with
  • US (FDA)
CARA System

Cara Medical, Ltd.

Cleared 2026-02-20

Registered with
  • US (FDA)
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

Bd

Cleared 2026-02-20

Registered with
  • US (FDA)
CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

CASEBIOSCIENCE INC.

Cleared 2026-02-20

Registered with
  • US (FDA)
LF Process Indicator Tape for Steam Sterilization

Intertape Polymer, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
Safety Heel Lancet

Ningbo Medsun Medical Co., Ltd.

Cleared 2026-02-20

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
TrueFit Bolus

Adaptiiv Medical Technologies, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
VERTICALE GPS Instruments

Silony Medical GmbH

Cleared 2026-02-19

Registered with
  • US (FDA)
Meniscus Versaflex

GM Dos Reis Industria e Comercio Ltda.

Cleared 2026-02-19

Registered with
  • US (FDA)
LacertaMatrix

Lacerta Life Sciences

Cleared 2026-02-19

Registered with
  • US (FDA)
Retrograde Coronary Sinus Perfusion Cannulae

Medtronic, Inc

Cleared 2026-02-19

Registered with
  • US (FDA)
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Efofex, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

Cmt Health Pte., Ltd.

Cleared 2026-02-19

Registered with
  • US (FDA)
Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434)

Beckman Coulter, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
ATLAS™ Expandable Osteotomy Wedge System

Mirus, LLC

Cleared 2026-02-19

Registered with
  • US (FDA)
Portable Dental X-ray Device (GT-1)

Guilin Refine Medical Instrument Co., Ltd.

Cleared 2026-02-19

Registered with
  • US (FDA)
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor

Stryker Leibinger

Cleared 2026-02-19

Registered with
  • US (FDA)
Acclarent Aera Eustachian Tube Balloon Dilation System

ACCLARENT INC.

Cleared 2026-02-19

Registered with
  • US (FDA)
SkinStylus SteriLock MicroSystem (MP1209SL)

Esthetic Medical, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

Alphatec Spine, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
Monaco RTP System (6.3)

Elekta Solutions AB

Cleared 2026-02-19

Registered with
  • US (FDA)
AuST CSP Introducer

Centerpoint Systems

Cleared 2026-02-19

Registered with
  • US (FDA)
BioMimics 3D® Vascular Stent System

Veryan Medical Limited

Cleared 2026-02-19

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Erchonia DPN Laser (Model# EVRL)

ERCHONIA CORPORATION

Cleared 2026-02-19

Registered with
  • US (FDA)
AS Software Version Asera

As Software, Inc.

Cleared 2026-02-19

Registered with
  • US (FDA)
UROVYSION BLADDER CANCER KIT

Abbott Molecular, Inc.

Cleared 2026-02-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Alere NT-proBNP for Alinity i

Axis-Shield Diagnostics, Ltd.

Cleared 2026-02-18

Registered with
  • US (FDA)
VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT

Abbott Molecular, Inc.

Cleared 2026-02-18

Registered with
  • US (FDA)
  • UK (MHRA)
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Cleared 2026-02-18

Registered with
  • US (FDA)
Mobility Scooter (S3)

Shenzhen Zhimahuaerkai Technology Co, Ltd

Cleared 2026-02-18

Registered with
  • US (FDA)
1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

Stryker Endoscopy

Cleared 2026-02-18

Registered with
  • US (FDA)
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

Methyl Co., Ltd.

Cleared 2026-02-18

Registered with
  • US (FDA)
Nobel Biocare S Series Implants

Nobel Biocare AB

Cleared 2026-02-18

Registered with
  • US (FDA)
BTL-754FF

Btl Industries, Ltd.

Cleared 2026-02-18

Registered with
  • US (FDA)