BEUDAMED
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    Tyber Medical Wedge System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304239227·

    AGXO

    FDA UDI
    Oticon A/S·05707131287779·H100V2, RITE 312 WL TC AGXO

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962104545·OVAL BURR, 4.5MM, COMPATIBLE W/L

    SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962102558·DISPOSABLE ARTHROSCOPIC 4.5mm OVAL BURR, COMPAT...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    COMP PRIMARY STEM 11MM MINI

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBF·September 4, 2018

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 6, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 8, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 5, 2008

    Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·October 10, 2018

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018

    Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 19, 2018

    OSS 3CM ELLIP DIAPHYSEAL SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2019

    OSS 3CM ELLIP DIAPHYSEAL SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 10, 2019

    ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; 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