12 results
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26ms
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Sources: EU EUDAMED, US FDA
MULTIX U. BUCKY TABLE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REGUTHERM 952 THERMOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
PINN SECTOR HA ACET CUP 62MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 9, 2014
VPAP WITH QUICKNAV AMERICAS
FDA Adverse Event
Death
·RESMED LTD.·Product code MNS·October 19, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 31, 2007
CT GLENOID REVERSE SHOULDER KIT CUSTOM-MADE WITH 4.75 LOCKING SCREW HOLES
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·November 17, 2016
BD SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 11, 2019
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024