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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
RODIN Cement

Belport Company, Inc., Gingi-Pak

Cleared 2025-09-02

Registered with
  • US (FDA)
VELMENI for DENTISTS(V4D)

Velmeni, Inc.

Cleared 2025-09-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

Ignite Orthomotion

Cleared 2025-09-02

Registered with
  • US (FDA)
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)

Philips Medizin Systeme Boblingen GmbH

Cleared 2025-09-02

Registered with
  • US (FDA)
Customized Abutment and Screw

Chengdu Besmile Medical Technology Co., Ltd.

Cleared 2025-09-02

Registered with
  • US (FDA)
Sonosite LX and Sonosite PX Ultrasound Systems

Fujifilm Sonosite Inc

Cleared 2025-08-29

Registered with
  • US (FDA)
IVA & AEON Cervical and Lumbar Cage System

K&J Consulting Corporation

Cleared 2025-08-29

Registered with
  • US (FDA)
GLAM LED Facial Mask (TB-2386F)

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.

Cleared 2025-08-29

Registered with
  • US (FDA)
FG Bone Graft B

Full Golden Biotech Corporation

Cleared 2025-08-29

Registered with
  • US (FDA)
PV01 PVDF Effort Sensor

Neurotronics, LLC

Cleared 2025-08-29

Registered with
  • US (FDA)
Erbe ESU Model VIO® 3n with Accessories

Erbe Elektromedizin GmbH

Cleared 2025-08-29

Registered with
  • US (FDA)
Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

Perfuze, Ltd.

Cleared 2025-08-29

Registered with
  • US (FDA)
G aenial Universal Injectable II

GC AMERICA INC.

Cleared 2025-08-29

Registered with
  • US (FDA)
CurvaFix Low Profile System

Curvafix, Inc.

Cleared 2025-08-29

Registered with
  • US (FDA)
SIRIUS Endoscope System (PR-SI-1230)

Precision Robotics (Hong Kong) Limited

Cleared 2025-08-29

Registered with
  • US (FDA)
Primescan 2

Dentsply Sirona

Cleared 2025-08-29

Registered with
  • US (FDA)
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

Merit Medical Ireland, Ltd.

Cleared 2025-08-29

Registered with
  • US (FDA)
SurgiTwin

Twinsight

Cleared 2025-08-29

Registered with
  • US (FDA)
ArTT Augments and Buttresses and Bone Screws

Lima Corporate S.P.A.

Cleared 2025-08-29

Registered with
  • US (FDA)
PRAEVAorta®2

Nurea

Cleared 2025-08-29

Registered with
  • US (FDA)
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

Geneseeq Technology, Inc.

Cleared 2025-08-29

Registered with
  • US (FDA)
EZ™ IV Administration Set

Epic Medical Pte. , Ltd.

Cleared 2025-08-29

Registered with
  • US (FDA)
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

RAUMEDIC AG

Cleared 2025-08-29

Registered with
  • US (FDA)
  • AU (TGA)
Fetal Pillow

Coopersurgical Inc.,

Cleared 2025-08-29

Registered with
  • US (FDA)
  • UK (MHRA)
Edwards eSheath Optima introducer set

Edwards Lifesciences, LLC

Cleared 2025-08-29

Registered with
  • US (FDA)
  • Canada (Health Canada)
Invisalign System

Align Technology Ltd

Cleared 2025-08-29

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
Sunrise

Sunrise

Cleared 2025-08-29

Registered with
  • US (FDA)
Regenesis EMS Chair

Trinity Medical Solutions

Cleared 2025-08-29

Registered with
  • US (FDA)
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2025-08-28

Registered with
  • US (FDA)
Powder-Free Vinyl Exam Gloves, clear

Basic Medical Technology, Inc.

Cleared 2025-08-28

Registered with
  • US (FDA)
JAZZ Spinal System

Implanet, S.A.

Cleared 2025-08-28

Registered with
  • US (FDA)
Medical Gas Analyzer (AG200)

Prior Care Science Technology, Ltd.

Cleared 2025-08-28

Registered with
  • US (FDA)
OTC 4-Channel Rechargeable TENS Unit

Changsha Anxiang Medical Technology Co., Ltd.

Cleared 2025-08-28

Registered with
  • US (FDA)
RadiForce GX570; RadiForce GX570-AR

EIZO Corporation

Cleared 2025-08-28

Registered with
  • US (FDA)
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

THERMO FISHER SCIENTIFIC INC.

Cleared 2025-08-28

Registered with
  • US (FDA)
Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System

Imperative Care, Inc.

Cleared 2025-08-28

Registered with
  • US (FDA)
CT:VQ

4Dmedical Limited

Cleared 2025-08-28

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Definium Tempo Select

Ge Hualun Medical Systems Co. , Ltd.

Cleared 2025-08-28

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

Alphatec Spine, Inc.

Cleared 2025-08-28

Registered with
  • US (FDA)
SmartPilot YpsoMate NS-A2.25

Ypsomed AG

Cleared 2025-08-28

Registered with
  • US (FDA)
Somfit D

Compumedics Limited

Cleared 2025-08-28

Registered with
  • US (FDA)
  • Canada (Health Canada)
truFlex

Syrma Johari MedTech Limited

Cleared 2025-08-28

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
JARVIS Glenoid Reverse Shoulder Prosthesis

FH INDUSTRIE

Cleared 2025-08-28

Registered with
  • US (FDA)
da Vinci SP Firefly Imaging System

Intuitive Surgical, Inc.

Cleared 2025-08-28

Registered with
  • US (FDA)
ELID (Endoscopic Less Invasive Decompression) System

Lesspine Innovations

Cleared 2025-08-27

Registered with
  • US (FDA)
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Basic Medical Technology, Inc.

Cleared 2025-08-27

Registered with
  • US (FDA)
Dermalage

Infection Elimination Solutions, LLC

Cleared 2025-08-27

Registered with
  • US (FDA)
KnoxFog Anti-fogging Device

Uv One Hygienics, Inc.

Cleared 2025-08-27

Registered with
  • US (FDA)
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

Nanjing Yinuoji Medical Technology Co., Ltd.

Cleared 2025-08-27

Registered with
  • US (FDA)
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

Hangzhou Clongene Biotech Co., Ltd.

Cleared 2025-08-27

Registered with
  • US (FDA)