BEUDAMED
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    MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3D

    FDA UDI
    Rmo, Inc.·00885797100184·3D PALATAL APPLIANCE ASST OF 6

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607511·SKYTRON 6700, 6701 3" STANDARD

    CORTISOL LIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    OXFORD PARTIAL KNEE SYSTEM SIZE AA WITH SLOTS LEFT MEDIAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·December 21, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2013

    BREAST PUMP

    FDA Adverse Event
    Other ·PLAYTEX·Product code HGX·September 6, 2014

    AU681-02E CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.

    FDA Recall
    Terminated ·Theken Spine Llc·Product code KWQ·July 29, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024