16 results · 19ms · Sources: EU EUDAMED, US FDA

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FTRD System Set

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

TROUTMAN NEEDLE HOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896074613·TROUTMAN NEEDLE HOLDER WITHOUT LOCK VERY DELICA...

TROUTMAN NEEDLE HOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093782·TROUTMAN NEEDLE HOLDER WITHOUT LOCK EXTRA DELIC...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

Sklar®

FDA UDI
SKLAR CORPORATION·10649111092084·SKLARCUT MAYO SCISS STR 5 1/2"

YOBOSHI DENTAL UNIT

FDA 510(k)
FDA Class 1 ·Dental

AMBU BLUE SENSOR NEO AND NEO X

FDA 510(k)
FDA Class 2 ·Cardiovascular

ESON 2 NASAL MASK

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

SYRINGE 3ML SALINE FILL CHINA SP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code NGT·January 18, 2024

TINBN VANGUARD INT PS ANAT FM R 65MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·March 7, 2025

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Malfunction ·MPRI·Product code NVN·June 8, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

FDA Enforcement
Class II ·Ongoing·Abbott·November 8, 2023

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024