15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COPA AMD
FDA 510(k)
FDA Unclassified
·Unknown
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
FDA 510(k)
FDA Class 2
·Immunology
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
NEURON DELIVERY CATHETER 053
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·March 16, 2010
DELTA CER FM HD 036/-4MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 23, 2026
UNKNOWN AVANTAGE HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 6, 2025
PROLITE
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·April 23, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 9, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·July 29, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 2, 2017
32MM COCR BIOMET FEM HD -3 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 30, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018