BEUDAMED
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    ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008

    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code KOG·February 19, 2010

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    FDA Recall
    Terminated ·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016

    DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.

    FDA Recall
    Terminated ·Minntech Corp·Product code FEB·June 15, 2010

    Flexible Intubation Fiberscope, Model # 11301AB1

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EOQ·April 24, 2019

    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·December 14, 2007

    SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EKR·January 17, 2013

    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DER·May 16, 2018

    SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EKR·January 17, 2013

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

    Clinical Chemistry Apolipoprotein A1, List Number 9D92-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005

    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EKR·December 27, 2017

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEB·June 23, 2016

    Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.

    FDA Recall
    Terminated ·Kerr Corporation·Product code EMA·December 2, 2010

    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

    FDA Recall
    Terminated ·Kerr Corporation·Product code LYC·October 25, 2012