BEUDAMED
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    SHANGHAI GANGHAI MODEL GIKO 1400

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

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776316471·Hirschman Anoscope

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136742·Ti-6Al-4V ALIF Implant 34 X 28, 15mm Height 20°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136773·Ti-6Al-4V ALIF Implant 34 X 28, 21mm Height 20°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136766·Ti-6Al-4V ALIF Implant 34 X 28, 19mm Height 20°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136759·Ti-6Al-4V ALIF Implant 34 X 28, 17mm Height 20°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136735·Ti-6Al-4V ALIF Implant 34 X 28, 13mm Height 20°...

    ENDOFLIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STICK NET

    FDA 510(k)
    FDA Class 2 ·Dental

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    LEAD MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·April 17, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 11, 2011

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    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

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017