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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
TRUDERMAL Pro (ZLD-390)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2025-08-14

Registered with
  • US (FDA)
FilmArray GI Control Panel M238

Maine Molecular Quality Controls, Inc.

Cleared 2025-08-14

Registered with
  • US (FDA)
  • UK (MHRA)
Cassette Autoclave (ACA5)

Guangzhou Ajax Medical Equipment Co., Ltd.

Cleared 2025-08-14

Registered with
  • US (FDA)
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

Biofire Diagnostics, Inc.

Cleared 2025-08-14

Registered with
  • US (FDA)
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

Geistlich-Pharma

Cleared 2025-08-14

Registered with
  • US (FDA)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

SHENZHEN MLAY INTELLIGENT TECHNOLOGY CO., LTD.

Cleared 2025-08-14

Registered with
  • US (FDA)
mOm Essential Incubator (ME1)

Mom Incubators Limited

Cleared 2025-08-14

Registered with
  • US (FDA)
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

STRYKER SUSTAINABILITY SOLUTIONS

Cleared 2025-08-14

Registered with
  • US (FDA)
AeroJet Ventilation Catheter

Pipeline Medical Products, LLC

Cleared 2025-08-13

Registered with
  • US (FDA)
T2 Alpha Femur Retrograde Nailing System

Stryker Corp.

Cleared 2025-08-13

Registered with
  • US (FDA)
KARL STORZ HOPKINS Telescopes for Urology

Karl Storz SE & CO.KG

Cleared 2025-08-13

Registered with
  • US (FDA)
HS Fiber

Riverpoint Medical

Cleared 2025-08-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Avive Automated External Defibrillator (AED) System

Avive Solutions, Inc.

Cleared 2025-08-13

Registered with
  • US (FDA)
Electrotherapy Electrodes

Baisheng Medical Co., Ltd.

Cleared 2025-08-13

Registered with
  • US (FDA)
Bone Screw

Osstem Implant Co., Ltd.

Cleared 2025-08-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Bruker Daltonics GmbH & Co KG

Cleared 2025-08-13

Registered with
  • US (FDA)
DOLORCLAST Focused Shock Waves

E.M.S Electro Medical Systems S.A

Cleared 2025-08-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

Cleared 2025-08-13

Registered with
  • US (FDA)
RelieVRx (Pico G3)

Appliedvr, Inc.

Cleared 2025-08-13

Registered with
  • US (FDA)
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

Unibeauty (Hubei) Technology Co., Ltd.

Cleared 2025-08-13

Registered with
  • US (FDA)
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Nuwellis, Inc.

Cleared 2025-08-13

Registered with
  • US (FDA)
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

Unimed Medical Supplies, Inc.

Cleared 2025-08-13

Registered with
  • US (FDA)
DS Core Diagnosis

Dentsply Sirona

Cleared 2025-08-12

Registered with
  • US (FDA)
CuffGuard

IDMED

Cleared 2025-08-12

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
14F Duo-Flow® Side X Side Double Lumen Catheter

MEDICAL COMPONENTS, INC.

Cleared 2025-08-12

Registered with
  • US (FDA)
Eko Foundation Analysis Software with Transformers (EFAST)

Eko Health, Inc

Cleared 2025-08-12

Registered with
  • US (FDA)
Sulopenem SPM 2 µg

Liofilchem S. R. L.

Cleared 2025-08-12

Registered with
  • US (FDA)
HOTWIRE™ System RF Generator and Footswitch (optional accessory)

Atraverse Medical

Cleared 2025-08-12

Registered with
  • US (FDA)
Straumann RidgeFit Implants

Institut Straumann AG

Cleared 2025-08-12

Registered with
  • US (FDA)
UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)

Zhejiang UE Medical Corp

Cleared 2025-08-11

Registered with
  • US (FDA)
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

Cnc Technologies

Cleared 2025-08-11

Registered with
  • US (FDA)
eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

ANKER INNOVATIONS LIMITED

Cleared 2025-08-11

Registered with
  • US (FDA)
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

Univlabs Technologies Private Limited

Cleared 2025-08-11

Registered with
  • US (FDA)
Outlook Surgical Versa One System (8900139)

Resnent, LLC

Cleared 2025-08-11

Registered with
  • US (FDA)
OxyMinder Pro (10310)

Bio-Med Device, Inc.

Cleared 2025-08-11

Registered with
  • US (FDA)
Identity Revision Humeral Stems

Zimmer Inc

Cleared 2025-08-11

Registered with
  • US (FDA)
XERF

Lutronic Corporation

Cleared 2025-08-11

Registered with
  • US (FDA)
  • AU (TGA)
MagVenture TMS Therapy System

Tonica Elektronik A/S

Cleared 2025-08-11

Registered with
  • US (FDA)
External Fixation Bone Distractor

Paragon 28, Inc

Cleared 2025-08-11

Registered with
  • US (FDA)
Aqua Medical RF Vapor Ablation System

Aqua Medical, Inc.

Cleared 2025-08-08

Registered with
  • US (FDA)
Plain Water-based Lubricant

GLOBAL PROTECTION CORP.

Cleared 2025-08-08

Registered with
  • US (FDA)
Water-based Lubricant

GLOBAL PROTECTION CORP.

Cleared 2025-08-08

Registered with
  • US (FDA)
Diode laser device (BM091)

Hebei Newangie Technology Co., Ltd.

Cleared 2025-08-08

Registered with
  • US (FDA)
Coretech Compression System (Coretech RHB3003)

Vive Health LLC

Cleared 2025-08-08

Registered with
  • US (FDA)
MICOR 700 with Auto I/A

Carl Zeiss Meditec Cataract Technology, Inc.

Cleared 2025-08-08

Registered with
  • US (FDA)
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Guangzhou Red Pine Medical Instrument Co, Ltd

Cleared 2025-08-08

Registered with
  • US (FDA)
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

Becton Dickinson and Company

Cleared 2025-08-08

Registered with
  • US (FDA)
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Amdt Holdings, Inc.

Cleared 2025-08-08

Registered with
  • US (FDA)
Parkell Pit and Fissure Sealant

Parkell, Inc.

Cleared 2025-08-08

Registered with
  • US (FDA)
swiftPro System (SWF-SPS); Swift System (SWF-SYS)

Emblation , Ltd.

Cleared 2025-08-08

Registered with
  • US (FDA)