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

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

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 21, 2018

    JUDKINS PACK

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Enforcement
    Class II ·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020

    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

    FDA Enforcement
    Class II ·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020

    1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 3, 2017

    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·March 27, 2013

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·February 20, 2013

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·April 13, 2022

    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 26, 2018

    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·March 7, 2018

    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

    FDA Enforcement
    Class II ·Terminated·Handicare Usa Inc·October 18, 2017

    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

    FDA Enforcement
    Class II ·Terminated·ErgoSafe Products, LLC (DBA) Prism Medical·November 25, 2015

    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

    FDA Enforcement
    Class II ·Terminated·Central Purchasing LLC DBA Harbor Freight Tools·April 16, 2014

    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·June 14, 2017

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    FDA Enforcement
    Class II ·Terminated·Med-Mizer, Inc.·May 14, 2014

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    FDA Enforcement
    Class II ·Terminated·Philips North America LLC·September 15, 2021

    Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.

    FDA Enforcement
    Class II ·Terminated·ErgoSafe Products, LLC (DBA) Prism Medical·November 25, 2015

    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·January 15, 2014

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    FDA Enforcement
    Class II ·Terminated·Med-Mizer, Inc.·May 14, 2014

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    FDA Enforcement
    Class II ·Terminated·Med-Mizer, Inc.·May 14, 2014