BEUDAMED
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    Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-3620 Explorer-Single End #23 SE. +H658100362003. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005

    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 8, 2017

    HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·March 29, 2004

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018