BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05055343897423·Femoral Posterior Augment 10 mm Sizes 5, 6 & 7

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·54026704624336·RUSCH Color Coded Guedel Airway Length 70mm Tra...

    Logical PX-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215000639·

    FRAMELOCK; FRAMELOCK ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    R3 XLPE ANTEVERTED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3I T3® TAPERED IMPLANT 4/3 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·May 20, 2025

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code OAE·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·June 13, 2011

    OSS NON-MOD TIB PLATE LONG 67

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 22, 2023

    OSS CEMENTED IM STEM 11X150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·May 22, 2023

    Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

    FDA Enforcement
    Class II ·Terminated·Corin Ltd·October 6, 2021

    Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

    FDA Recall
    Terminated ·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code MEH·July 28, 2021

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015