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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.

3,665 devices · when each source was last refreshed

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

Device
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

Macrolux Medical Technology Co., Ltd.

Cleared 2026-04-08

Registered with
  • US (FDA)
TL-10 Laparoscopic Scope Cleaner

Scopix , Ltd.

Cleared 2026-04-08

Registered with
  • US (FDA)
Wearable Breast Pump (Model S21A)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-04-08

Registered with
  • US (FDA)
iStent Trabecular Micro-Bypass Stent System

Glaukos

Cleared 2026-04-08

Registered with
  • US (FDA)
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

Suzhou Shenyun Medical Equipment Co., Ltd.

Cleared 2026-04-08

Registered with
  • US (FDA)
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)

Shenzhen Root Innovation Technology Co., Ltd.

Cleared 2026-04-08

Registered with
  • US (FDA)
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

STERIS SAS

Cleared 2026-04-08

Registered with
  • US (FDA)
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

Boston Scientific Corp

Cleared 2026-04-08

Registered with
  • US (FDA)
CATAMARAN SI Joint Fusion System

Tenon Medical, Inc.

Cleared 2026-04-08

Registered with
  • US (FDA)
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

Anumana, Inc.

Cleared 2026-04-07

Registered with
  • US (FDA)
Elecsys Anti-HBc II

Roche Diagnostics GmbH

Cleared 2026-04-07

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
PearlMatrix™ Peptide Enhanced Bone Graft

Cerapedics, LLC

Cleared 2026-04-07

Registered with
  • US (FDA)
AuST Steerable Sheath

Centerpoint Systems

Cleared 2026-04-07

Registered with
  • US (FDA)
  • Canada (Health Canada)
Power Wheelchair (OS-R-M01S)

Beijing OrionStar Technology Co, Ltd

Cleared 2026-04-07

Registered with
  • US (FDA)
IWD-Gel™

InnovaCorium, Inc.

Cleared 2026-04-07

Registered with
  • US (FDA)
Elecsys Anti-HBc IgM

Roche Diagnostics GmbH

Cleared 2026-04-07

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)

Zhejiang Shuyou Surgical Instrument Co Ltd

Cleared 2026-04-07

Registered with
  • US (FDA)
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

Shenzhen Root Innovation Technology Co., Ltd.

Cleared 2026-04-07

Registered with
  • US (FDA)
Firefighter™ Pro PTCA Balloon Catheter

Shanghai MicroPort Medical (Group) Co., Ltd.

Cleared 2026-04-07

Registered with
  • US (FDA)
Voyager DSLT (430840610)

Belkin Vision, Ltd.

Cleared 2026-04-07

Registered with
  • US (FDA)
Warming System

Hangzhou Tappa Medical Technology Co, Ltd

Cleared 2026-04-07

Registered with
  • US (FDA)
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

Basic Medical Technology, Inc.

Cleared 2026-04-07

Registered with
  • US (FDA)
Elecsys Anti-HAV IgM

Roche Diagnostics GmbH

Cleared 2026-04-07

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
i-FACTOR® Peptide Enhanced Graft Substitute

Cerapedics, LLC

Cleared 2026-04-07

Registered with
  • US (FDA)
PrimeSight UltraView System

Cogentix Medical, Inc.

Cleared 2026-04-07

Registered with
  • US (FDA)
Light-curing Coloring Materials (ALCM)

Aidite (Qinhuangdao) Technology Co., Ltd.

Cleared 2026-04-06

Registered with
  • US (FDA)
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

Zhuhai Pusen Medical Technology Co., Ltd.

Cleared 2026-04-06

Registered with
  • US (FDA)
AETOS Shoulder System - CONCELOC Glenoids

Smith & Nephew, Inc.

Cleared 2026-04-06

Registered with
  • US (FDA)
VANES Delivery System (VDS)

ZOLL Respicardia, Inc.

Cleared 2026-04-06

Registered with
  • US (FDA)
SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

Hironic Co., Ltd.

Cleared 2026-04-06

Registered with
  • US (FDA)
SV70 Ventilator (SV70)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-04-06

Registered with
  • US (FDA)
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote, S.P.A.

Cleared 2026-04-06

Registered with
  • US (FDA)
APERTO Lucent MRI System

FUJIFILM Corporation

Cleared 2026-04-06

Registered with
  • US (FDA)
in2 Smart (in2S)

Virility Medical

Cleared 2026-04-06

Registered with
  • US (FDA)
GLOSSY COAT (15ML)

YAMAHACHI DENTAL MFG, CO

Cleared 2026-04-06

Registered with
  • US (FDA)
ProSomnus RPMO2 OSA Device (RPMO2 OSA)

Prosomnus Sleep Technologies, Inc.

Cleared 2026-04-06

Registered with
  • US (FDA)
SPECTRA Wearable 2

Uzinmedicare Co.

Cleared 2026-04-06

Registered with
  • US (FDA)
Ricoh 3D for Healthcare Bolus

Ricoh 3D For Healthcare, LLC

Cleared 2026-04-06

Registered with
  • US (FDA)
MAGENTIQ-COLO (ME-APDS)

Magentiq Eye, Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
Etiometry Platform

Etiometry, Inc.

Cleared 2026-04-03

Registered with
  • US (FDA)
  • Canada (Health Canada)
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

Med-El Elektromedizinische Geräte GmbH

Cleared 2026-04-03

Registered with
  • US (FDA)
TYBER MEDICAL TRAUMA SCREW

Tyber Medical, LLC

Cleared 2026-04-03

Registered with
  • US (FDA)
Electric Wheelchair (AL-208S-063)

Zhongshan A&J Medical Equipment Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
Hot and Cold Compression System (A02-C-032)

Chengdu Cryo-Push Medical Technology Co.,Ltd

Cleared 2026-04-03

Registered with
  • US (FDA)
  • AU (TGA)
Life Saving Tourniquet

TW Medical

Cleared 2026-04-03

Registered with
  • US (FDA)
Disposable Stone Extraction Basket

Zhejiang Soudon Medical Technology Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);

Med-El Elektromedizinische Geräte GmbH

Cleared 2026-04-03

Registered with
  • US (FDA)
Blueprint Patient-Specific Instrumentation

Stryker Corporation (Tornier, S.A.S.)

Cleared 2026-04-03

Registered with
  • US (FDA)
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

Cixi Ruihong Electric Appliance Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)