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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.

3,392 devices · when each source was last refreshed

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

Device
Diazyme Colorimetric Lithium Assay

Diazyme Laboratories

Cleared 2025-08-01

Registered with
  • US (FDA)
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)

Shenzhen Huachuangtong Industrial Co., Ltd.

Cleared 2025-08-01

Registered with
  • US (FDA)
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

Access Vascular, Inc.

Cleared 2025-08-01

Registered with
  • US (FDA)
eCO2 3D

Lutronic Corporation

Cleared 2025-07-31

Registered with
  • US (FDA)
  • AU (TGA)
Sleep Watch

AMBULATORY MONITORING, INC

Cleared 2025-07-31

Registered with
  • US (FDA)
BeneVision Central Monitoring System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2025-07-31

Registered with
  • US (FDA)
  • Canada (Health Canada)
YSIO X.pree

Siemens Medical Solutions

Cleared 2025-07-31

Registered with
  • US (FDA)
REMEX Xcam6

Remedi Co., Ltd.

Cleared 2025-07-31

Registered with
  • US (FDA)
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

Roche Molecular Systems, Inc.

Cleared 2025-07-31

Registered with
  • US (FDA)
ArteraAI Prostate

Artera Inc

Cleared 2025-07-31

Registered with
  • US (FDA)
NextAR(TM) Spine

Medacta International S.A.

Cleared 2025-07-31

Registered with
  • US (FDA)
Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2025-07-31

Registered with
  • US (FDA)
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

United Orthopedic Corporation

Cleared 2025-07-31

Registered with
  • US (FDA)
Genius AI Detection 2.0

Hologic Inc

Cleared 2025-07-31

Registered with
  • US (FDA)
Biograph Trinion

Siemens Medical Solutions USA, Inc.

Cleared 2025-07-31

Registered with
  • US (FDA)
Mpact Constrained Liner

Medacta International S.A.

Cleared 2025-07-31

Registered with
  • US (FDA)
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

Zimmer Biomet

Cleared 2025-07-31

Registered with
  • US (FDA)
Stabilis SA Cervical Stand-Alone System (Various PNs)

Acuity Surgical Devices, LLC

Cleared 2025-07-30

Registered with
  • US (FDA)
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

Bausch & Lomb Incorporated

Cleared 2025-07-30

Registered with
  • US (FDA)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

E.O.S. CO., LTD.

Cleared 2025-07-30

Registered with
  • US (FDA)
TENS and EMS Unit

Changsha Anxiang Medical Technology Co., Ltd.

Cleared 2025-07-30

Registered with
  • US (FDA)
  • Canada (Health Canada)
T65 (9016E061-)

Tonica Elektronik A/S

Cleared 2025-07-30

Registered with
  • US (FDA)
SpineSite Endoscope System

HYDROCISION INC.

Cleared 2025-07-30

Registered with
  • US (FDA)
TSK Syringe

TSK Laboratory, Japan

Cleared 2025-07-30

Registered with
  • US (FDA)
  • Canada (Health Canada)
CORUS™ Navigation System-GX

Providence Medical Technology, Inc.

Cleared 2025-07-30

Registered with
  • US (FDA)
Intraosseous Infusion Needles

SPECTRUM VASCULAR

Cleared 2025-07-30

Registered with
  • US (FDA)
ArteVu

Cardio Ring Technologies, Inc. Taiwan Branch

Cleared 2025-07-30

Registered with
  • US (FDA)
Tyber Medical Distal Radius Plating System

Tyber Medical, LLC

Cleared 2025-07-30

Registered with
  • US (FDA)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

Hartalega NGC Sdn. Bhd.

Cleared 2025-07-30

Registered with
  • US (FDA)
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)

Shenzhen Lifotronic Technology Co, Ltd

Cleared 2025-07-30

Registered with
  • US (FDA)
Iconix Speed Anchor; Iconix Speed HA+ Anchor

Riverpoint Medical

Cleared 2025-07-30

Registered with
  • US (FDA)
Micro Catheter

Suzhou Zenith Vascular SciTech Limited

Cleared 2025-07-30

Registered with
  • US (FDA)
Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Cleared 2025-07-30

Registered with
  • US (FDA)
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

Olympus Medical Systems Corporation

Cleared 2025-07-29

Registered with
  • US (FDA)
Cios Spin

Siemens Medical Solutions USA, Inc.

Cleared 2025-07-29

Registered with
  • US (FDA)
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

Infobionic, Inc.

Cleared 2025-07-29

Registered with
  • US (FDA)
SImmetry+ System

Sivantage

Cleared 2025-07-29

Registered with
  • US (FDA)
PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

Prognosys Medical Systems Private Limited

Cleared 2025-07-29

Registered with
  • US (FDA)
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

Edan Instruments, Inc

Cleared 2025-07-29

Registered with
  • US (FDA)
BD Plastipak Syringe

Becton Dickinson and Company

Cleared 2025-07-29

Registered with
  • US (FDA)
Forcyte Autograft Harvest Kit

Forcyte Medical, LLC

Cleared 2025-07-29

Registered with
  • US (FDA)
Sleepiz One+ (2.5)

Sleepiz AG

Cleared 2025-07-29

Registered with
  • US (FDA)