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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
AvertD and AvertD Buccal Sample Collection Kit

AUTOGENOMICS, INCORPORATED

Cleared 2026-05-20

Registered with
  • US (FDA)
The Circadia C300 System (C300)

Circadia Health, Inc.

Cleared 2026-05-20

Registered with
  • US (FDA)
NEXUS Aortic Arch Stent Graft System

Endospan Ltd

Cleared 2026-05-20

Registered with
  • US (FDA)
  • UK (MHRA)
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

Shenzhen Soga Technology Co., Ltd.

Cleared 2026-05-19

Registered with
  • US (FDA)
OrthoEasy Pal; OrthoEasy Pal Long Neck

Bernhard Förster GmbH (Bernhard Foerster Ltd.)

Cleared 2026-05-19

Registered with
  • US (FDA)
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Pegavision Corporation

Cleared 2026-05-19

Registered with
  • US (FDA)
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

DiaDent Group International

Cleared 2026-05-19

Registered with
  • US (FDA)
Guardant360® Liquid CDx

Guardant Health, Inc.

Cleared 2026-05-19

Registered with
  • US (FDA)
FilmArray TF Control Panel M527

Maine Molecular Quality Controls, Inc.

Cleared 2026-05-19

Registered with
  • US (FDA)
FITBONE® Transport and Lengthening System

Orthofix Srl

Cleared 2026-05-19

Registered with
  • US (FDA)
MR5 Activ Pro

MULTI RADIANCE MEDICAL

Cleared 2026-05-19

Registered with
  • US (FDA)
  • Canada (Health Canada)
Taperloc® Complete Hip Stem

Biomet, Inc.

Cleared 2026-05-19

Registered with
  • US (FDA)
LIAISON PLEX Gastrointestinal Flex Assay

Luminex Corporation

Cleared 2026-05-19

Registered with
  • US (FDA)
Laport

Sejong Medical Co., Ltd.

Cleared 2026-05-19

Registered with
  • US (FDA)
  • EU (EUDAMED)
HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories

Heartsine Technologies, Inc.

Cleared 2026-05-18

Registered with
  • US (FDA)
Coude Sleeved IC; Coude Plus Sleeved IC

Hollister, Inc.

Cleared 2026-05-18

Registered with
  • US (FDA)
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure

Boston Scientific Corp

Cleared 2026-05-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Trilogy Transcatheter Heart Valve System

JenaValve Technology Inc

Cleared 2026-05-18

Registered with
  • US (FDA)
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Cercare Medical AS

Cleared 2026-05-18

Registered with
  • US (FDA)
AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™

Boston Scientific Corp

Cleared 2026-05-18

Registered with
  • US (FDA)
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap

O&M Halyard, Inc.

Cleared 2026-05-18

Registered with
  • US (FDA)
MOSES Raydar™

Boston Scientific Corp

Cleared 2026-05-18

Registered with
  • US (FDA)
MagtraceTM and Sentimag(R) Magnetic Locatization System

Endomagnetics Ltd.,

Cleared 2026-05-18

Registered with
  • US (FDA)
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES

ETHICON LLC

Cleared 2026-05-18

Registered with
  • US (FDA)
G-CEM UNIVERSAL

GC AMERICA INC.

Cleared 2026-05-18

Registered with
  • US (FDA)
RhinAer+ Stylus

Aerin Medical, Inc.

Cleared 2026-05-18

Registered with
  • US (FDA)
BluEX Cervical Expandable Cage System

L&K BIOMED CO., LTD

Cleared 2026-05-16

Registered with
  • US (FDA)
Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-05-15

Registered with
  • US (FDA)
TruSelect™ 2.6 Microcatheter

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
cobas® liat CT/NG nucleic acid test

Roche Molecular Systems, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
  • UK (MHRA)
SubtleHD-CT (1.x)

Subtle Medical, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
Jada System (Jada-2002)

Organon, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+

Bausch & Lomb Incorporated

Cleared 2026-05-15

Registered with
  • US (FDA)
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Depuy Ireland UC

Cleared 2026-05-15

Registered with
  • US (FDA)
NxStage System One with NxView

Fresenius Medical Care Renal Therapies Group, LLC

Cleared 2026-05-15

Registered with
  • US (FDA)
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super

Wuhan United Imaging Healthcare Co., Ltd.

Cleared 2026-05-15

Registered with
  • US (FDA)
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Teleflex Medical Sdn Bhd

Cleared 2026-05-15

Registered with
  • US (FDA)
Signatera™ CDx

Natera, Inc

Cleared 2026-05-15

Registered with
  • US (FDA)
Fixation Tool (Model 6616)

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
DF-1 Plug (Model 6996)

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-05-15

Registered with
  • US (FDA)
Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour

Q-Med AB

Cleared 2026-05-15

Registered with
  • US (FDA)
  • AU (TGA)
Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)

Alcon Laboratories

Cleared 2026-05-15

Registered with
  • US (FDA)
UNiD™ Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic)

Cleared 2026-05-15

Registered with
  • US (FDA)
Ventana® P/T Lumbar Interbody System

Spinal Elements, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin

Micro Therapeutics Inc., d/b/a ev3 Neurovascular

Cleared 2026-05-15

Registered with
  • US (FDA)
Neurophet SCALE PET

Neurophet., Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
cobas® liat CT/NG/MG nucleic acid test

Roche Molecular Systems, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
  • UK (MHRA)
KARL STORZ Laryngoscopes and Accessories

Karl Storz Endoscopy-America, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)

Hycor Biomedical, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)