BEUDAMED
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    Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569752·CoRoent Ant TLIF Ti, 12x11x30mm 0°

    POYA 3.5mm Posteromedial Proximal Tibia Plate, 10 Hole, Left

    FDA UDI
    Bonebridge AG·07640187462555·

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00842180149984·3MM DIA., 20CM, INCISION WOUND CLOSURE DEVICE S...

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·00190660194871·Corneal trephine blade, short, 8.0mm length, 13...

    VANGUARD CR POROUS FEMORAL - RIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·November 18, 2019

    ARCOM SERIES A PATELLA THIN 3 PEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·November 19, 2019

    VANGUARD CR TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 18, 2019

    BIOMET CC CRUCIATE TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·November 18, 2019

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702412710·E3/AG/CT-E-KC/NOP2,5-T-OH/BR

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702780437·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

    Airway Mobilescope

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 23, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 21, 2022

    POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN)

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code LJS·September 24, 2020

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 3, 2014

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JID·August 24, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012