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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
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)
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)
KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O

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)
Ceribell Brain Monitor Headband

Ceribell, Inc.

Cleared 2026-04-03

Registered with
  • US (FDA)
ClearCheck (RADCC V2.7)

Radformation

Cleared 2026-04-03

Registered with
  • US (FDA)
LSSA (NP-200)

Newpong Co Ltd

Cleared 2026-04-03

Registered with
  • US (FDA)
neuropacs

Automated Imaging Diagnostics, LLC

Cleared 2026-04-03

Registered with
  • US (FDA)
Single-use Video Scope; PB Digital Controller

Mirco-Tech (Nanjing) Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

Med-El Elektromedizinische Geräte GmbH

Cleared 2026-04-03

Registered with
  • US (FDA)
HYALEX® MTP Hemiarthroplasty Implant

Hyalex Orthopaedics, Inc.

Cleared 2026-04-03

Registered with
  • US (FDA)
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le

Euclid Vision Corporation

Cleared 2026-04-02

Registered with
  • US (FDA)
FLASH Flex™ Aorto-Ostial Angioplasty System

Verge Medical, Inc.

Cleared 2026-04-02

Registered with
  • US (FDA)
Tahoe Unicondylar Knee System with TiNbN Overcoat

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

Cleared 2026-04-02

Registered with
  • US (FDA)
LifeShield™ Infusion Safety Software Suite

ICU Medical, Inc

Cleared 2026-04-02

Registered with
  • US (FDA)
  • Canada (Health Canada)
Wireless Probe Type Ultrasound Scanner

Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay

Becton Dickinson and Company

Cleared 2026-04-02

Registered with
  • US (FDA)
  • AU (TGA)
Disposable Infusion Bag for Parenteral Nutrition

Beijing L&Z Medical Technology Development Co, Ltd

Cleared 2026-04-02

Registered with
  • US (FDA)
Cryopush Cold Compression Device (A02-P-001)

Chengdu Cryo-Push Medical Technology Co.,Ltd

Cleared 2026-04-02

Registered with
  • US (FDA)
SMART M-CELL Bone Marrow Concentration System

Miracell Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
SMART M-CELL PRP Concentration System

Miracell Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
Embrace Hydrogel Embolic System (HES)

Instylla, Inc.

Cleared 2026-04-02

Registered with
  • US (FDA)
BELLIGER ACE

Genoray Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
  • EU (EUDAMED)