BEUDAMED
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    Paneffort AAMI Level 3 Isolation Gown

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

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586015809·

    PMT CORPORATION

    FDA UDI
    PMT CORPORATION·00650551003915·INTERCONNECTION CABLE, 17 CONTACT, INLINE CONNE...

    LIFE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    NUVASIVE NVJJB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 21, 2008

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 12, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023