BEUDAMED
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    TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040112·RING PESSARY W/O SUPPORT #2

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00401121·

    NAV SOLID TAP FOR 5.5mm FASTENER

    FDA UDI
    Osteocentric Technologies, Inc.·00810097803541·NAV SOLID TAP FOR 5.5mm FASTENER

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00816777026712·

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101120·Distractor, Smooth Paddle, Lordotic, 12mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312L0101120·Distractor, Smooth Paddle, 12mm

    BIPOLAR COAGULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    PROLENE HERNIA SYSTEM

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 8, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 5, 2011

    STRAIGHT PLATE 8 HOLE

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'R.L.·Product code HRS·May 7, 2008

    Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112.

    FDA Recall
    Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013