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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.

3,665 devices · when each source was last refreshed

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

Device
Dormiva Anti-Snoring Mouth Guard

Koncept Innovators, LLC

Cleared 2026-05-14

Registered with
  • US (FDA)
Bonalive Maxillofacial

BonAlive Ltd

Cleared 2026-05-14

Registered with
  • US (FDA)
ART.1-US

SeeTreat Pty Ltd

Cleared 2026-05-14

Registered with
  • US (FDA)
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

Hiossen, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
MatriDerm Dermal Matrix

Medskin Solutions Dr. Suwelack AG

Cleared 2026-05-14

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Suction Pump (SU-90)

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
Any-Etch

Mediclus Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
  • EU (EUDAMED)
ARIES Anterior Cervical Plate Systems

ZheJiang Decans Medical Devices Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
MYNX ACE VASCULAR CLOSURE DEVICE

Cordis US Corp

Cleared 2026-05-14

Registered with
  • US (FDA)
TriMed® Compression Screws

Trimed Pvt Ltd

Cleared 2026-05-14

Registered with
  • US (FDA)
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)

Hunan Accurate Bio-Medical Technology Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
SubtleHD-PET (1.x)

Subtle Medical, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

Providence Medical Technology, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
RAYMO Mobile X-ray System (Model: RAYMO)

Drgem Corporation

Cleared 2026-05-14

Registered with
  • US (FDA)
Palmtop Ultrasound Diagnostic System (MT10P/MT10)

Mytech Intelligence (Shenzhen) Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
ENTity USB Videoscope System

OPTIM LLC

Cleared 2026-05-14

Registered with
  • US (FDA)
SmartClip Delivery Catheter (ADR-1715)

Elucent Medical, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
Y-Knotless™ Flex Anchors

Conmed Corporation

Cleared 2026-05-13

Registered with
  • US (FDA)
Organ Care System™ (OCS™) Lung

TransMedics, Inc.

Cleared 2026-05-13

Registered with
  • US (FDA)
VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)

Acist Medical Systems

Cleared 2026-05-13

Registered with
  • US (FDA)
StatSeal Disc

Merit Medical Systems, Inc.

Cleared 2026-05-13

Registered with
  • US (FDA)
iCast Covered Stent System

Atrium Medical Corp.

Cleared 2026-05-13

Registered with
  • US (FDA)
SURGIMAGE SIM 1000H Fluorescence Imaging Platform

Surgimage Corporation

Cleared 2026-05-13

Registered with
  • US (FDA)
Morph

BeauBrain Healthcare, Inc.

Cleared 2026-05-13

Registered with
  • US (FDA)
ActaStim-S

THERAGEN INC.

Cleared 2026-05-13

Registered with
  • US (FDA)
Organ Care System (OCS™) Liver

TransMedics, Inc.

Cleared 2026-05-13

Registered with
  • US (FDA)
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable

Acist Medical Systems

Cleared 2026-05-13

Registered with
  • US (FDA)
OPTIMIZER® Smart Mini System

Impulse Dynamics (Usa), Inc.

Cleared 2026-05-13

Registered with
  • US (FDA)
Electric Wheelchair (Y207BL)

Jiangsu Intco Medical Products Co., Ltd.

Cleared 2026-05-13

Registered with
  • US (FDA)
Automatic Micro Needle System (CODE-X)

Woorhi Mechatronics Co Ltd

Cleared 2026-05-13

Registered with
  • US (FDA)
Electric Breast Pump (HL-3058 II Pro)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

Cleared 2026-05-13

Registered with
  • US (FDA)
Portable Neuromodulation Stimulator (PoNS)

HELIUS MEDICAL, INC.

Cleared 2026-05-13

Registered with
  • US (FDA)
SPECTRUM BREAST IMPLANTS

Mentor Worldwide, LLC

Cleared 2026-05-12

Registered with
  • US (FDA)
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

Promimic AB

Cleared 2026-05-12

Registered with
  • US (FDA)
CellDx-Tissue

Datar Cancer Genetics Private Limited

Cleared 2026-05-12

Registered with
  • US (FDA)
Senhance Ultrasonic System

Asensus Surgical, Inc.

Cleared 2026-05-12

Registered with
  • US (FDA)
ENDURANT & ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AORTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM; ENDURANT IIs STENT GRAFT

Medtronic Vascular

Cleared 2026-05-12

Registered with
  • US (FDA)
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

Hindernis DE Mexico, S.A.P.I. DE C.V.

Cleared 2026-05-12

Registered with
  • US (FDA)
VersaLift Expandable System

Life Spine, LLC

Cleared 2026-05-12

Registered with
  • US (FDA)
CorVision® (91-205-Z0014)

CorVent® Medical, Inc.

Cleared 2026-05-12

Registered with
  • US (FDA)
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)

SHENZHEN KINGBOOM TECHNOLOGY CO., LTD

Cleared 2026-05-12

Registered with
  • US (FDA)
Promisemed VeriEcto Automatic Biopsy Needles

Promisemed Hangzhou Meditech Co., Ltd.

Cleared 2026-05-12

Registered with
  • US (FDA)
OSTEOMNI SPINAL CAGES SYSTEM

OSTEOMNI, Inc.

Cleared 2026-05-12

Registered with
  • US (FDA)
Rayvolve

Azmed Sas

Cleared 2026-05-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
myLEDmask 2 (MJ-144)

Light Tree Ventures Europe B.V.

Cleared 2026-05-12

Registered with
  • US (FDA)
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

Verathon Medical (Canada) Ulc

Cleared 2026-05-11

Registered with
  • US (FDA)
Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-05-11

Registered with
  • US (FDA)
Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Cleared 2026-05-11

Registered with
  • US (FDA)
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

Shenzhen IMDK Medical Technology Co, Ltd

Cleared 2026-05-11

Registered with
  • US (FDA)
SAYA 86 Radial Access Guide Catheter

Asahi Intecc Co., Ltd.

Cleared 2026-05-11

Registered with
  • US (FDA)