BEUDAMED
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    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

    FDA Enforcement
    Class II ·Terminated·Parker Medical·July 27, 2016

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code 000·May 7, 2012

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 25, 2014

    First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·August 18, 2020

    Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·November 6, 2008

    Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Alere San Diego·Product code DKZ·June 10, 2011

    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DKZ·June 3, 2013

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    MEDTOXscan Reader

    FDA Recall
    Terminated ·Medtox Diagnostics Inc·Product code DKZ·February 8, 2008

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011

    Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000

    FDA Recall
    Terminated ·Macan Engineering and Manufacturing Co., Inc.·Product code EKZ·April 5, 2006

    Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code DKZ·February 12, 2007

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Recall
    Terminated ·Sarken, Inc.·Product code DKZ·July 29, 2013