10 results · 44ms · Sources: EU EUDAMED, US FDA

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AOC SOLUBLE IMPLANT MATERIAL

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526189768·*USE K011231*LEVAMED ACTIVE ANKL SUP BL

RPI REPLACEMENT PHOTOTHERAPY LIGHTS

FDA 510(k)
FDA Class 2 ·General Hospital

CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code CAW·April 29, 2013

ACCU-CHEK RAPID D

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·April 12, 2011

WALLSTENT RX BILIARY ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code FGE·July 25, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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