BEUDAMED
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    Catalyst R1 Reverse Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASTRONOMER PLUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 23, 2024

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·August 12, 2011

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·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