15 results · 28ms · Sources: EU EUDAMED, 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