11 results · 20ms · Sources: EU EUDAMED, US FDA

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Quantum Ventilation Module

FDA 510(k)
FDA Class 2 ·Cardiovascular

StarDental Instrument Solutions

FDA UDI
DENTALEZ, INC.·D7022027330·INSTR MG DE JACQ 2YS-3YS

Sklar®

FDA UDI
SKLAR CORPORATION·10649111179549·METZENBAUM NDL HLDR STR 7 1/4"

VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·March 16, 2020

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·October 16, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·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