BEUDAMED
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    MEDLINE ANTI-EMBOLISM STOCKING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ortho™ BioClone™ PLUS Anti-N

    FDA UDI
    ALBA BIOSCIENCE LIMITED·05060242472923·This Anti-N reagent is for the in vitro detecti...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515017245·Vascular Fcps, cvd jaw, 1x2 tth 5 1/2"

    PATIENT MONITOR, MODEL PM50

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOSORB 1 PIN 50X1.3MM KIT

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code OVZ·October 3, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 3, 2013

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 22, 2011

    ADULT NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·July 2, 2015

    Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025