HaRi
Start Free→

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
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)

BioHorizons Implant Systems, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
LightningWire Transseptal Puncture System (TPS)

ElectroWire Medical

Cleared 2026-06-26

Registered with
  • US (FDA)
Arterial Pressure Monitoring Set/Tray

SPECTRUM VASCULAR

Cleared 2026-06-26

Registered with
  • US (FDA)
PhAST instrument and PhAST Blood Culture Gram-negative Panel

Phast Corp.

Cleared 2026-06-26

Registered with
  • US (FDA)
i-STAT Crea cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
Arthrex FiberButton

Arthrex, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
TENS 7000 Rechargeable 4 Channel (TENS 7000H)

Shenzhen Dongdixin Technology Co., Ltd.

Cleared 2026-06-26

Registered with
  • US (FDA)
COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use

Merz North America, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
Durata Leads; Optisure Leads; UltiSync Leads

Abbott Medical

Cleared 2026-06-26

Registered with
  • US (FDA)
SALGINA 2.5mm Distal Radius System

Bonebridge AG

Cleared 2026-06-26

Registered with
  • US (FDA)
MammoScreen® (5)

Therapixel

Cleared 2026-06-26

Registered with
  • US (FDA)
VERTICALE Navigation Instruments

Silony Medical GmbH

Cleared 2026-06-26

Registered with
  • US (FDA)
RxSight Light Adjustable Lens; Light Delivery Device

Rxsight, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
  • AU (TGA)
AMDS Hybrid Prosthesis

Artivion, Inc.

Cleared 2026-06-26

Registered with
  • US (FDA)
SimplGuide

Pendracare

Cleared 2026-06-25

Registered with
  • US (FDA)
IntraOp Alignment System; CONTOUR3D Bending System

Alphatec Spine, Inc.

Cleared 2026-06-25

Registered with
  • US (FDA)
TriClip Delivery System

Abbott Medical

Cleared 2026-06-25

Registered with
  • US (FDA)
  • AU (TGA)
DVT Garment

Vistar Medical Supplies Co,Ltd

Cleared 2026-06-25

Registered with
  • US (FDA)
  • EU (EUDAMED)
MiPACS V5 (1.0.0)

Apryse Software Corp

Cleared 2026-06-25

Registered with
  • US (FDA)
GYNECARE INTERCEED™ Absorbable Adhesion Barrier

ETHICON LLC

Cleared 2026-06-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture

ETHICON LLC

Cleared 2026-06-25

Registered with
  • US (FDA)
Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

GN Hearing A/S

Cleared 2026-06-25

Registered with
  • US (FDA)
syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc.

Cleared 2026-06-25

Registered with
  • US (FDA)
ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)

Longeviti Neuro Solutions, LLC

Cleared 2026-06-25

Registered with
  • US (FDA)
EliA CTD 13 Screen

Phadia AB

Cleared 2026-06-25

Registered with
  • US (FDA)
A5 Anesthesia System (A5); A7 Anesthesia System (A7)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-06-25

Registered with
  • US (FDA)
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System

Arthrex, Inc.

Cleared 2026-06-25

Registered with
  • US (FDA)
UNIQA Dental Implants System

UNIQA DENTAL LTD

Cleared 2026-06-25

Registered with
  • US (FDA)
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Weyo Surgical Technology Ltd.

Cleared 2026-06-25

Registered with
  • US (FDA)
iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

Neuralytix, LLC

Cleared 2026-06-25

Registered with
  • US (FDA)
Belotero Volume (+) Lidocaine

Merz North America, Inc.

Cleared 2026-06-25

Registered with
  • US (FDA)
G-Series Grind Guard

ASESSO HEALTH, Inc.

Cleared 2026-06-25

Registered with
  • US (FDA)
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

Abbott Medical

Cleared 2026-06-25

Registered with
  • US (FDA)
  • AU (TGA)
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

Seers Technology Co., Ltd.

Cleared 2026-06-25

Registered with
  • US (FDA)
VELYS™ Robotic-Assisted Solution

Depuy Ireland UC

Cleared 2026-06-25

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
ATTUNE Total Knee System; ATTUNE Cementless Knee System

Depuy Ireland UC

Cleared 2026-06-25

Registered with
  • US (FDA)
BedDot (G1)

Intelligent Dots, LLC

Cleared 2026-06-25

Registered with
  • US (FDA)
Wearable breast pump (QY-101, QY-102, QY-108)

Shenzhen Qinyi Electronic Technology Co., Ltd.

Cleared 2026-06-25

Registered with
  • US (FDA)
SilverCeuticals® Antimicrobial Wound Gel

Silverceuticals, Inc.

Cleared 2026-06-24

Registered with
  • US (FDA)
HD Camera Head OLYMPUS CH-S200-08-LB

Olympus Medical Systems Corporation

Cleared 2026-06-24

Registered with
  • US (FDA)
Target Xtra Detachable Coil

Stryker Neurovscular

Cleared 2026-06-24

Registered with
  • US (FDA)
CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B)

Medtronic, Inc

Cleared 2026-06-24

Registered with
  • US (FDA)
CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB)

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-06-24

Registered with
  • US (FDA)
Endoform Dermal Template

Aroa Biosurgery

Cleared 2026-06-24

Registered with
  • US (FDA)
  • Canada (Health Canada)
Enhanced Boundary for PCCT

Ge Medical Systems, Inc.

Cleared 2026-06-24

Registered with
  • US (FDA)
TOUCH® CMC 1 Prosthesis

Keri Medical SA

Cleared 2026-06-24

Registered with
  • US (FDA)
  • AU (TGA)
Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability

Medtronic, Inc

Cleared 2026-06-24

Registered with
  • US (FDA)
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

Hangzhou Jimushi Meditech Co., Ltd.

Cleared 2026-06-24

Registered with
  • US (FDA)
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

Sw Technologies, Inc.

Cleared 2026-06-24

Registered with
  • US (FDA)
Ceribell Neurology Review Software

Ceribell, Inc.

Cleared 2026-06-24

Registered with
  • US (FDA)