11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ELITE R/F SPOT FILM DRIVE
FDA 510(k)
FDA Class 2
·Radiology
2.5 x 50CM LIGHTWEIGHT GALILEAN LOUPE - 902403
Device
EU MDR
·
Eu Md Class 1
·Keeler Ltd·On the market·1 country
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
FDA 510(k)
FDA Class 2
·Dental
NOVOFINE 31 DISPOSABLE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010
OMNIPOD 5 PODS
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·February 27, 2026
OMNIPOD 5 PODS
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·March 30, 2026
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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