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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
Embryo Predict

Alife Health Inc

Cleared 2026-05-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

Shenzhen Root Innovation Technology Co., Ltd.

Cleared 2026-05-15

Registered with
  • US (FDA)
NovaLine Tubing Set for Hemodialysis (BL 124)

Bain Medical Equipment (Guangzhou) Co., Ltd.

Cleared 2026-05-15

Registered with
  • US (FDA)
LifeVest® Wearable Defibrillator

Zoll Manufacturing Corporation

Cleared 2026-05-15

Registered with
  • US (FDA)
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
medXion NEXUS

medXion Technologies, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
Varion Thoracolumbar Fixation System

Kyocera Medical Technologies Inc. (KMTI)

Cleared 2026-05-15

Registered with
  • US (FDA)
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)
Vein Pick (Model 6541)

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
VENTANA HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc.

Cleared 2026-05-15

Registered with
  • US (FDA)
  • UK (MHRA)
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)
Hex Wrench (#2) (Model 6501)

Boston Scientific Corp

Cleared 2026-05-15

Registered with
  • US (FDA)
RADIESSE® Injectable Implant, RADIESSE® Hands

Merz North America, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
  • AU (TGA)
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)
GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis

W. L. Gore and Associates, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Bonalive Maxillofacial

BonAlive Ltd

Cleared 2026-05-14

Registered with
  • US (FDA)
RADIESSE 1.3CC AND 0.3CC

Merz North America, Inc.

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

Medskin Solutions Dr. Suwelack AG

Cleared 2026-05-14

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

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
GORE® EXCLUDER® Conformable AAA Endoprosthesis

W. L. Gore and Associates, Inc.

Cleared 2026-05-14

Registered with
  • US (FDA)
  • UK (MHRA)
ARIES Anterior Cervical Plate Systems

ZheJiang Decans Medical Devices Co., Ltd.

Cleared 2026-05-14

Registered with
  • US (FDA)
Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure

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)
Heart Ware™ Ventricular Assist System (HVAD)

Medtronic, Inc

Cleared 2026-05-14

Registered with
  • US (FDA)
COAPTITE® AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Merz North America, 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)
Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar

Medtronic, Inc

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)
Any-Etch

Mediclus Co., Ltd.

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)