16 results · 22ms · Sources: EU EUDAMED, US FDA

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CATS®-D Tonometer Prism

FDA 510(k)
FDA Class 2 ·Ophthalmic

Ophthalmic Hooks

FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)

Disposable Iris Retract

FDA UDI
KATENA PRODUCTS, INC.·00841668114339·FLEXIBLE IRIS RETRACTORS 1 PK of 5

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113653·SUB-TENONS CANNULA 19GA 25MM

Fujifilm Ultrasonic Processor

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

SYDNEY IVF EMBRYO BIOPSY MEDIUM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MONOJECT SYRINGE

FDA Adverse Event
Malfunction ·COVIDIEN·Product code FMF·June 10, 2022

AGX

FDA UDI
Widex A/S·05706069749861·Audigy AGXWU-IP (Dark brown S-110 ) Right

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

ATTAIN ABILITY PLUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code LKK·July 3, 2013

M2A MAGNUM SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 6, 2017

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021