BEUDAMED
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    UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DOOLEN BONE CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083202·DOOLEN BONE CLAMP WITH SPEED LOCK LARGE SIZE

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964112362·The ENDO CARRY-ON Procedure Kit contains all of...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520622·Split Tube Retractor, Size Ø22x40 mm

    PRESCOTT'S SURGICAL SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMMUNO-TROL LOW CELLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO TEST STRIPS

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    UNKNOWN ZIMMER FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code KWY·May 24, 2011

    BONE SCREW SELF-TAPPING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2025

    32MM I.D. SIZE D HIGH WALL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2025

    G7 OSSEOTI MULTIHOLE 50MM D

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2025

    FEMORAL STEM PRESS-FIT COLLARLESS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 26, 2025

    PRESIDIO 10 CERE 6MMX26CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·May 10, 2021

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025