BEUDAMED
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    VITEK 2 GRAM POSITIVE DAPTOMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MedGyn Pessary Cube w/drain # 9

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050075·Cube Pessary is used treat uterine prolapse.

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025651·PREF LING ARCH 35 CUNITI UP 017X017 SZ2 PK10

    Orthex

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132143223·Ring, Half 75mm

    Orthex

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731111913·Orthex Half Ring 75mm SB

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981165536·CORTICAL SHANK, SOLID, 5.0 X 75

    A&E Medical / Disposable Suction Coagulator

    FDA UDI
    A & E MEDICAL CORPORATION·10841291105053·Suction Coagulator, 1 per pouch

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036025663·

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987165530·CORTICAL SHANK, SOLID, 5.0 X 75

    Xpress Minimally Invasive Pedicle Screw System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697T0730500751·7.5 CANNULATED TAP

    TEKNIQUE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    STRYKER CORPORATION·07613327051605·Stryker/ACMI Scope Adapter

    Ambassador

    FDA UDI
    Choice Spine, LP·10885862269379·

    Xpress Minimally Invasive Pedicle Screw System

    FDA UDI
    Xtant Medical Holdings, Inc.·M697T073050075DL1·7.5 DUAL LEAD, CANNULATED TAP

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 10, 2013

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·April 4, 2011

    NA

    FDA Adverse Event
    Injury ·Product code FWM·May 20, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022