11 results
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22ms
·
Sources: EU EUDAMED, US FDA
MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
FDA 510(k)
FDA Class 2
·Neurology
ACUMED
FDA UDI
Acumed LLC·10806378092916·SLIC Screw® Removal Tray Base
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MORPHEUS
FDA 510(k)
FDA Class 2
·Dental
OXF ANATOMIC BRG RT MD SIZE 4
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·May 9, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 6, 2007
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024