BEUDAMED
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    BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Digital Analogue RB/WB

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074444·

    GLOVER COOLEY BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921004120·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED

    GLOVER COOLEY BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896089686·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVE...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002059·ISO Chin Plate with Window, 12mm Step

    OPEL-C

    FDA UDI
    MEDITECH SPINE, LLC·B16711004120S0·

    Cure OPEL-C

    FDA UDI
    SpineArt SA·07640375236067·DOUBLE BARREL DRILL GUIDE, FIXED

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100412001·IN-OVATION® C Base Rx 022/LL1&2 -1T 2A

    FLEXIBLE ENDOSCOPIC SCISSORS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISION R/F TILTING TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2024

    BIO - OSS

    FDA Adverse Event
    Injury ·GEISTLICH PHARMA·Product code NPM·November 16, 2015

    Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009

    ADULT DUAL HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·December 28, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 8, 2013

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·September 19, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011

    MULTI-FUNCTION ELECTRODE - PADPRO

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MKJ·January 10, 2013

    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·January 22, 2014

    Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HTE·September 24, 2013