BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    PANALOK QUICKANCHOR ORTHOCORD

    FDA UDI
    DEPUY MITEK, LLC·10886705002009·PANALOK RC QUICKANCHOR Plus Poly (L-lactide) Ab...

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8962121370·Forceps children's pattern KLEIN upper ...

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMFORTGLIDE INTERMITENT CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CADD

    FDA UDI
    ICU MEDICAL, INC.·15019517165753·

    CADD

    FDA UDI
    ICU MEDICAL, INC.·10610586043543·

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 18, 2017

    ALARIS® PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 10, 2020

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 8, 2021

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 8, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·September 17, 2018

    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021