BEUDAMED
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    PROFILER 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040064785·MOLAR BAND LR 1ST 34 (2)

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00630211·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

    MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHTLANCE LASER SKIN PERFORATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 17, 2013

    REFLOTRON CREATININE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JFY·April 19, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015