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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.

3,670 devices · when each source was last refreshed

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

Device
Sway System Sports Plus

Sway Medical, Inc.

Cleared 2026-10-18

Registered with
  • US (FDA)
KIM BLUE

DESARROLLO E INVESTIGACION MEDICA ARAGONESA, S.L.

Cleared 2026-10-16

Registered with
  • US (FDA)
cCeLL - In vivo

VPIX Medical, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)

Xiamen Compower Medical Tech Co, Ltd

Cleared 2026-10-16

Registered with
  • US (FDA)
Endox Test Strips

IBT Scientific

Cleared 2026-10-16

Registered with
  • US (FDA)
MODO DUO Electric Pump (B11621, B11673)

Tomy International

Cleared 2026-10-16

Registered with
  • US (FDA)
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)

Sofradim Production

Cleared 2026-10-16

Registered with
  • US (FDA)
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)

Skycade Med Corporation

Cleared 2026-10-16

Registered with
  • US (FDA)
BCS Bioceramic Sealer

BCS Device Pte., Ltd.

Cleared 2026-10-16

Registered with
  • US (FDA)
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)

Becton Dickinson and Company

Cleared 2026-10-16

Registered with
  • US (FDA)
Sensinel Cardiopulmonary Management (CPM) System

Analog Devices, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
AVIEW Aorta Metrics

Coreline Soft Co.,Ltd

Cleared 2026-10-16

Registered with
  • US (FDA)
Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-10-16

Registered with
  • US (FDA)
TMINI™ Miniature Robotic System

THINK Surgical, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
Lilium one (USM330)

Lilium Otsuka Co., Ltd.

Cleared 2026-10-16

Registered with
  • US (FDA)
Endox High Level Disinfectant

Whiteley USA, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

Hong Qiangxing (Shenzhen) Electronics Limited

Cleared 2026-10-16

Registered with
  • US (FDA)
Restrata®

Acera Surgical, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens

Bausch & Lomb Incorporated

Cleared 2026-10-16

Registered with
  • US (FDA)
Amber Arte

Hass Corp.

Cleared 2026-10-16

Registered with
  • US (FDA)
Carecube Negative Pressure Isolation Chamber (1BY)

Carecubes, Inc.

Cleared 2026-10-16

Registered with
  • US (FDA)
Giranel Guiding Sheath Set

Kossel Medtech (Suzhou) Co., Ltd.

Cleared 2026-10-15

Registered with
  • US (FDA)
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)

Guangzhou Aimooe Technology Co., Ltd.

Cleared 2026-10-15

Registered with
  • US (FDA)
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)

Carl Zeiss Meditec Cataract Technologies

Cleared 2026-10-15

Registered with
  • US (FDA)
twiist Loop Algorithm

Deka Research & Development Corp.

Cleared 2026-10-15

Registered with
  • US (FDA)
epi-ConneKt™ Wound Matrix

MLM Biologics, Inc.

Cleared 2026-10-15

Registered with
  • US (FDA)
Single-Use EBUS Balloon

Micro-Tech (Nanjing) Co., Ltd .

Cleared 2026-10-15

Registered with
  • US (FDA)
Park's Pectus System

Tdm Co., Ltd.

Cleared 2026-10-15

Registered with
  • US (FDA)
Oncomine ™ Dx Express Test

Life Technologies Holdings Pte Ltd

Cleared 2026-10-15

Registered with
  • US (FDA)
The Circadia CX00 System (CX00)

Circadia Health, Inc.

Cleared 2026-10-15

Registered with
  • US (FDA)
Odys-SI Screw

Medyssey USA, Inc.

Cleared 2026-10-15

Registered with
  • US (FDA)
TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)

Carl Zeiss Meditec AG

Cleared 2026-10-15

Registered with
  • US (FDA)
INDIGO Aspiration System

Penumbra, Inc.

Cleared 2026-10-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Vantage Lumbar Decompression Kit

SurGenTec, LLC

Cleared 2026-10-14

Registered with
  • US (FDA)
KARL STORZ Flexible Video Neuro-Endoscope

Karl Storz SE & CO.KG

Cleared 2026-10-14

Registered with
  • US (FDA)
Power Wheelchair (D39)

Anhui Jbh Medical Apparatus Co., Ltd.

Cleared 2026-10-14

Registered with
  • US (FDA)
Sterilization Cassette (CASS-1)

Alliedstar Medical Equipment Co, Ltd

Cleared 2026-10-14

Registered with
  • US (FDA)
Ntegrate Threaded Nail System

Nvision Biomedical Technologies, LLC

Cleared 2026-10-14

Registered with
  • US (FDA)
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

Shanghai Medi Astro Technology Co., Ltd.

Cleared 2026-10-14

Registered with
  • US (FDA)
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System

Intuitive Surgical, Inc.

Cleared 2026-10-14

Registered with
  • US (FDA)
Mediclose Cartridge System

Health Value Creation B.V., Trading AS Corporis Medical

Cleared 2026-10-14

Registered with
  • US (FDA)
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

CorDx, Inc.

Cleared 2026-10-14

Registered with
  • US (FDA)
308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)

Guangxi Hope Medical Devices Technology Co., Ltd.

Cleared 2026-10-14

Registered with
  • US (FDA)
Radius VSM and Accessories

Masimo Corp.

Cleared 2026-10-14

Registered with
  • US (FDA)
  • AU (TGA)
Electrically Powered Wheelchair (YC-01)

Yurob Rehabilitation Medical Co, Ltd

Cleared 2026-10-13

Registered with
  • US (FDA)
Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)

Keyue (Hangzhou) Medical Information Technology Co., Ltd.

Cleared 2026-10-13

Registered with
  • US (FDA)
Yomi S Robotic System

Neocis, Inc.

Cleared 2026-10-13

Registered with
  • US (FDA)
TECAR Therapy Device (TC2000, TC2001)

Shenzhen Dongdixin Technology Co., Ltd.

Cleared 2026-10-13

Registered with
  • US (FDA)
OrthoFit Aligner (OrthoFit Aligner A2)

Spident Co., Ltd.

Cleared 2026-10-13

Registered with
  • US (FDA)