16 results · 28ms · Sources: EU EUDAMED, US FDA

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CoreLink Navigation Instruments

FDA 510(k)
FDA Class 2 ·Neurology

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113997·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1201-1...

N/A

FDA UDI
Smith & Nephew, Inc.·00817470009590·FEMORAL LOCATOR HANDLE

Aveta Pearl Disposable Hysteroscope

FDA UDI
MEDITRINA, INC.·00850006759064·Aveta Pearl Disposable Hysteroscope for use wit...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970799·

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 30, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2013

PINN-A SECTOR ACET CUP 50MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 28, 2018

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·November 18, 2024

UROSKOP Omnia Max. Model Number: 10762473

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019