11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189768·*USE K011231*LEVAMED ACTIVE ANKL SUP BL
BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 15, 2023
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
BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 17, 2022
FORTIFY VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 13, 2014
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
20/30 PRIORITY PACK W/COPILOT
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAV·May 17, 2011
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020