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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.

3,392 devices · when each source was last refreshed

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

Device
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Shanghai AnQing Medical Instrument Co., Ltd.

Cleared 2025-08-27

Registered with
  • US (FDA)
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

QIAGEN GmbH

Cleared 2025-08-27

Registered with
  • US (FDA)
Additively Manufactured Aligner Resin

Aidite (Qinhuangdao) Technology Co., Ltd.

Cleared 2025-08-27

Registered with
  • US (FDA)
  • Canada (Health Canada)
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

Fysicon BV

Cleared 2025-08-27

Registered with
  • US (FDA)
Fetal & Maternal Monitor (F15A, F15A Air)

Edan Instruments, Inc

Cleared 2025-08-27

Registered with
  • US (FDA)
ThinPrep Processor and ThinPrep Imaging System

Hologic Inc

Cleared 2025-08-27

Registered with
  • US (FDA)
Phoenix Sinus Tarsi Stent System

Astra Orthomed, Inc.

Cleared 2025-08-27

Registered with
  • US (FDA)
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

DonneVie Medical Technology (Shanghai) Co., Ltd

Cleared 2025-08-27

Registered with
  • US (FDA)
VistaSoft 4.0 and VisionX 4.0

DURR DENTAL SE

Cleared 2025-08-27

Registered with
  • US (FDA)
Rapid DeltaFuse

Ischemaview, Inc.

Cleared 2025-08-26

Registered with
  • US (FDA)
Heager Medical Laser Family (Sabrina/Adolf)

Heager GmbH

Cleared 2025-08-26

Registered with
  • US (FDA)
Brainomix 360 Triage Stroke

Brainomix Limited

Cleared 2025-08-26

Registered with
  • US (FDA)
Ultra-Fast Vitri; Ultra-Fast Warm

Kitazato Corporation

Cleared 2025-08-26

Registered with
  • US (FDA)
Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)

Seplou (Zhuhai) Co., Ltd.

Cleared 2025-08-26

Registered with
  • US (FDA)
X-Wire Guidewire

Imperative Care, Inc.

Cleared 2025-08-26

Registered with
  • US (FDA)
PRO Pen Microneedling System (6883)

Dermalogica, LLC

Cleared 2025-08-25

Registered with
  • US (FDA)
  • AU (TGA)
NeuroEars-Anna™

Neuroears, Inc.

Cleared 2025-08-25

Registered with
  • US (FDA)
Cryocheck Chromogenic Factor VIII

Precision BioLogic Inc

Cleared 2025-08-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
DenMat Multilayered Zirconia Disc

Denmat Holding, LLC

Cleared 2025-08-25

Registered with
  • US (FDA)
Neurovascular Insight V1.0

Olea Medical

Cleared 2025-08-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Motor and Apex Module (MaAM)

Dentsply Sirona

Cleared 2025-08-25

Registered with
  • US (FDA)
Quantra QStat Cartridge

Hemosonics, LLC

Cleared 2025-08-25

Registered with
  • US (FDA)
Maxx Libertas Bipolar Hip Head (Bipolar Hip)

Maxx Orthopedics, Inc.

Cleared 2025-08-25

Registered with
  • US (FDA)
Sparrow Ascent

SPARK BIOMEDICAL, INC

Cleared 2025-08-25

Registered with
  • US (FDA)
  • Canada (Health Canada)
NobelZygoma TiUltra Implant system

Nobel Biocare AB

Cleared 2025-08-25

Registered with
  • US (FDA)
One-Fil Putty Injectable

Mediclus Co., Ltd.

Cleared 2025-08-22

Registered with
  • US (FDA)
  • UK (MHRA)
CoraForce Microcatheter, CoraFlex Microcatheter

Reflow Medical

Cleared 2025-08-22

Registered with
  • US (FDA)
EnDrive (EnDriveUS)

Advanced Technology Research (A.T.R.) S.R.L.

Cleared 2025-08-22

Registered with
  • US (FDA)
  • AU (TGA)
PROMO

Drgem Corporation

Cleared 2025-08-22

Registered with
  • US (FDA)
  • EU (EUDAMED)
Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2025-08-22

Registered with
  • US (FDA)
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec

Cardinalhealth

Cleared 2025-08-22

Registered with
  • US (FDA)
MammoScreen BD

Therapixel

Cleared 2025-08-22

Registered with
  • US (FDA)
CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set

Cerenovus, Inc.

Cleared 2025-08-22

Registered with
  • US (FDA)
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

Access Bio, Inc.

Cleared 2025-08-22

Registered with
  • US (FDA)
Stem Extension Line (USTAR II System)

United Orthopedic Corporation

Cleared 2025-08-22

Registered with
  • US (FDA)
CPS Locator 3D Delivery Catheter

Centerpoint Systems

Cleared 2025-08-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
GBrain MRI

Galileo Cds, Inc.

Cleared 2025-08-22

Registered with
  • US (FDA)
CARTO™ 3 EP Navigation System V8.1

Biosense Webster, Inc.

Cleared 2025-08-22

Registered with
  • US (FDA)
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

Ever Global (Vietnam) Enterprise Corp

Cleared 2025-08-21

Registered with
  • US (FDA)
Origin™

Nerv Technology Inc. (D.B.A.) Fluidai Medical

Cleared 2025-08-21

Registered with
  • US (FDA)
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

bioMérieux SA

Cleared 2025-08-21

Registered with
  • US (FDA)
InSee

Tidal Medical Technologies, LLC

Cleared 2025-08-21

Registered with
  • US (FDA)
Vista OS, Vista AI Scan, RTHawk

Vista Ai, Inc.

Cleared 2025-08-21

Registered with
  • US (FDA)
ClearTip FNA and FNB Types

Finemedix Co., Ltd.

Cleared 2025-08-21

Registered with
  • US (FDA)
Treace Medical Concepts (TMC) Implant Fixation System

Treace Medical Concepts, Inc.

Cleared 2025-08-21

Registered with
  • US (FDA)
Portable Oxygen Concentrator (JM-P50A)

Jiangsu Jumao X-Care Medical Equipment Co.,Ltd

Cleared 2025-08-21

Registered with
  • US (FDA)
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)

Shenzhen Fittop Health Technology Co., Ltd.

Cleared 2025-08-21

Registered with
  • US (FDA)
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)

Shenzhen Yicai Health Technology Co., Ltd.

Cleared 2025-08-21

Registered with
  • US (FDA)
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System

Dentsply Sirona

Cleared 2025-08-21

Registered with
  • US (FDA)
The Acumed Wrist Fixation System - 2.4mm Screws

Acumed LLC

Cleared 2025-08-21

Registered with
  • US (FDA)