BEUDAMED
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    Cios Select (VA21) Image Intensifier

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bendini

    FDA UDI
    Nuvasive, Inc.·00887517221155·Bendini Base, Rod Bender II Tray

    Trinity Acetabular Hip System

    FDA UDI
    CORIN LTD·05055343898581·Stem Insert (Size 2)

    ZEUS-L

    FDA UDI
    SPINAL ELEMENTS·00840916142025·ZEUS®-L Trial Inserter

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551068181·LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59...

    VisCalor

    FDA 510(k)
    FDA Class 2 ·Dental

    Face Mask

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

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 10, 2020

    SAFETY NEEDLE 25 G 1" FOR IMMUNIZATIONS

    FDA Adverse Event
    Malfunction ·UNK·Product code FMI·February 6, 2023

    SHIFENG SYRINGES AND NEEDLES FOR IMMUNIZATIONS

    FDA Adverse Event
    Malfunction ·CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.·Product code FMI·February 6, 2023

    SHIFENG

    FDA Adverse Event
    Malfunction ·CHENGDU XINJIN SHIFENG MEDICAL·Product code FMI·November 11, 2022

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·October 22, 2008

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·August 8, 2011

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020