BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    AMMONIA REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRAUMAONE SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036181048·

    TraumaOne SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00888233001472·

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0157070·Trial Drill Guide Tube, 7mm

    BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS

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

    OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ZIMMER BIOMET OMNIMAX SD XD SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code DZL·December 12, 2017

    55MM LFT STANDARD MAND

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·January 31, 2021

    OMNIMAX SD XD SCREW 2.0X7MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code DZL·February 22, 2022

    11MM/130 DEG TI CANNULATED TROCHANTERIC FIXATION NAIL

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·November 29, 2010

    SYNTHES 3.5MM SMALL FRAGMENT CORTICAL SCREWS

    FDA Adverse Event
    Injury ·SYNTHES·Product code HWC·January 10, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 7, 2014

    OMNIMAX ARCH BAR

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·December 12, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015