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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.

3,708 devices · when each source was last refreshed

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

Device
Introcan Safety® Deep Access XL IV Catheter

B Braun Medical Ltd

Cleared 2026-05-15

Registered with
  • US (FDA)
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)

Sonoscape Medical Corp.

Cleared 2026-05-15

Registered with
  • US (FDA)
ACC SUP VEIN PICK

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
Manual Tissue Removal Device

Suzhou AcuVu Medical Technology Co., Ltd.

Cleared 2026-05-15

Registered with
  • US (FDA)
Neurophet AQUA

Neurophet., Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr

Fortis Biosolutions Company Limited

Cleared 2026-05-14

Registered with
  • US (FDA)
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

Shenzhen Urion Technology Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
Briefcase-Triage

Aidoc Medical , Ltd.

Cleared 2026-05-14

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