BEUDAMED
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    MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098

    FDA 510(k)
    FDA Unclassified ·Unknown

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496062653·CURVY 140 OPAQUE, SIZE ML-XL, MOKA, GRADUATED C...

    MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MMN-1 COARSE MANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ENDURANT II

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code MIH·April 10, 2013

    LUMAX 540 HF-T

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code MRM·April 11, 2011

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·June 10, 2008

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·February 11, 2008

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015