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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
Elecsys Anti-SARS-CoV-2

Roche Diagnostics GmbH

Cleared 2025-12-17

Registered with
  • US (FDA)
  • UK (MHRA)
Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants

Motiva, USA, LLC

Cleared 2025-12-17

Registered with
  • US (FDA)
DuoprossTM Smart Cap (Type I)

Duopross Meditech Corporate

Cleared 2025-12-17

Registered with
  • US (FDA)
Vital™ Spinal Fixation System

Highridge Medical LLC

Cleared 2025-12-17

Registered with
  • US (FDA)
Intri26 Introducer Sheath

Inari Medical, Inc.

Cleared 2025-12-17

Registered with
  • US (FDA)
UltraSight Guidance

Ultrasight, Inc.

Cleared 2025-12-17

Registered with
  • US (FDA)
  • EU (EUDAMED)
NovaSure Model 10 RF Controller

Hologic Inc

Cleared 2025-12-17

Registered with
  • US (FDA)
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)

Shenzhen Comen Medical Instruments Co,Ltd

Cleared 2025-12-17

Registered with
  • US (FDA)
Neosoma Brain Mets

Neosoma, Inc.

Cleared 2025-12-17

Registered with
  • US (FDA)
TroClose 1200

Gordian Surgical, Ltd.

Cleared 2025-12-16

Registered with
  • US (FDA)
ADVIA Centaur Cytokeratin Fragment 21-1

Fujirebio Diagnostics,Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
IDENTIFY (5.0)

Varian Medical Systems inc

Cleared 2025-12-16

Registered with
  • US (FDA)
Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl

Bausch & Lomb Incorporated

Cleared 2025-12-16

Registered with
  • US (FDA)
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

SPECTRUM VASCULAR

Cleared 2025-12-16

Registered with
  • US (FDA)
Versius Surgical System (Versius Plus)

CMR Surgical Limited

Cleared 2025-12-16

Registered with
  • US (FDA)
IRISeg

Intuitive Surgical, Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
prolaio eVO2peak Module (Version 1.0)

Prolaio, Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
SKAN C PULSAR

SKANRAY TECHNOLOGIES LIMITED

Cleared 2025-12-16

Registered with
  • US (FDA)
Cambridge Partial Knee

Signature Orthopaedics Pty Ltd

Cleared 2025-12-16

Registered with
  • US (FDA)
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)

Pentax of America, Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht

Johnson&Johnson Surgical Vision Inc

Cleared 2025-12-16

Registered with
  • US (FDA)
Companion Spine DIAM™ Instrumentation

Companion Spine France SAS

Cleared 2025-12-16

Registered with
  • US (FDA)
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)

Guangzhou Red Pine Medical Instrument Co, Ltd

Cleared 2025-12-16

Registered with
  • US (FDA)
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

Zhejiang Geyi Medical Instrument Co, Ltd

Cleared 2025-12-16

Registered with
  • US (FDA)
VR® Personal Protective Level 3 Gown (VR Gowns)

PolyConversions, Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment

Bausch & Lomb Incorporated

Cleared 2025-12-16

Registered with
  • US (FDA)
Organ Care System (OCS) Heart System

TransMedics, Inc.

Cleared 2025-12-16

Registered with
  • US (FDA)
V series portable oxygen concentrator (V5, V5C, V6, V6C)

Shenzhen Harveymed Technology Co., Ltd.

Cleared 2025-12-16

Registered with
  • US (FDA)
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

Baxter Healthcare Corp

Cleared 2025-12-16

Registered with
  • US (FDA)
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)

Foshan Pingchuang Medical Technology Co., Ltd.

Cleared 2025-12-15

Registered with
  • US (FDA)
Paradigm System

PROPRIO, INC.

Cleared 2025-12-15

Registered with
  • US (FDA)
  • AU (TGA)
Erchonia CLX (Model # CFL)

ERCHONIA CORPORATION

Cleared 2025-12-15

Registered with
  • US (FDA)
V•Stick™ Vascular Access Set

Argon Medical Devices, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Cleared 2025-12-15

Registered with
  • US (FDA)
SleepRes PAP System

Sleepres, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
FemVue® Controlled Saline-Air Device (FSA-300)

Femasys, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
HyperVue™ Imaging System - Integrated

Spectrawave, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
Optilume™ BPH Catheter System

Urotronic, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
  • Canada (Health Canada)
MFUSE (MS001)

Machina Medical, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
OptiMesh Multiplanar Expandable Interbody Fusion System

Spineology, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
TEMBO Embolic System

Instylla, Inc.

Cleared 2025-12-15

Registered with
  • US (FDA)
Hypnos (369054-200)

Cadwell Industries, Inc.

Cleared 2025-12-14

Registered with
  • US (FDA)
Bio Arterial Deluxe (IC-BAP-DX)

Bio Compression Systems, Inc.

Cleared 2025-12-12

Registered with
  • US (FDA)
Pterygoid Indication for GM Helix Implants

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Cleared 2025-12-12

Registered with
  • US (FDA)
VizMark Preloaded Tissue Marker Device (VM-0001)

Breast-Med, Inc.

Cleared 2025-12-12

Registered with
  • US (FDA)
EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle

Exelint International, Co.

Cleared 2025-12-12

Registered with
  • US (FDA)
FUJIFILM Ultrasonic Endoscope EB-710US

FUJIFILM Corporation

Cleared 2025-12-12

Registered with
  • US (FDA)
Therapy US

Dmc Importacao E Exportacao DE Equipamentos Ltda

Cleared 2025-12-12

Registered with
  • US (FDA)
Revi System

Bluewind Medical , Ltd.

Cleared 2025-12-12

Registered with
  • US (FDA)