11 results · 21ms · Sources: EU EUDAMED, US FDA

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CombiDiagnost R90

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

Oph. Cystotomes

FDA UDI
KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA

GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION

FDA 510(k)
FDA Class 2 ·General Hospital

BD INTIMA II¿ IV CATHETER PRN ADAPTER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 10, 2022

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014

FREESTYLE LITE

FDA Adverse Event
Malfunction ·Product code NBW·July 2, 2013

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