BEUDAMED
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    REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001398·artVeneer life upper anteriors, CS, C4

    CCF Film Size 1 Horizontal Bitewing ORANGE Bite Block 6 pack

    FDA UDI
    CLIKTECH LLC·00856200001398·CCF Film Size 1 Horizontal Bitewing ORANGE Bite...

    LIFEPAK® 12 defibrillator/monitor

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873950715·LP12AABCBBBACBABAABAAAAALP12 MONITOR-DEFIB

    BIOCEL TEXTURED MAMMARY PROSTHESIS, 300 CC

    FDA Adverse Event
    MCGHAN MEDICAL CORP.·Product code FTR·February 17, 1994

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

    FDA 510(k)
    FDA Class 2 ·Hematology

    PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·September 11, 2025

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·September 9, 2025

    PURESEE IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MFK·May 21, 2026

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 13, 2013

    BIOMET BROACH HANDLE

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code HTQ·February 9, 2011

    OPTETRAK CEMENTED FINNED TIBIAL TRAY

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code HSH·February 23, 2008

    ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016