BEUDAMED
    11 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.

    FDA Enforcement
    Class II ·Terminated·Conseal International, Inc.·May 9, 2018

    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Enforcement
    Class II ·Terminated·3M Company/3m Espe Dental Products·September 4, 2013

    Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA SP. ZO.O.·September 24, 2014

    Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·October 1, 2014

    ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·September 14, 2016

    ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver with everyday patient handling routines, such as bed and chair related transfers. REF MFA1000M-L-L1 RM0255_7

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·December 19, 2018

    Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI: (01)05055982788106], BAB2101-01 [(01)05055982788007], BAB2102-01 [01)05055982796194], BAB3000-01 [(01)05055982788120], BAB3101-01 [(01)05055982788021], BAB3107-01[ (01)05055982796248], BAB5000-01 [UDI: (01)05055982788144]. and Concerto & Basic Shower Trolley Spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031,

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·March 18, 2020

    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·August 26, 2020

    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

    FDA Enforcement
    Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·October 6, 2021