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