BEUDAMED
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    NSI HEXED AND NON-HEXED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040128787·Explorer SE #23

    KALORE™

    FDA UDI
    Gc America Inc.·D0470036201·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...

    KALORE™

    FDA UDI
    Gc America Inc.·14548161291354·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159008814·Micro Clamp

    Temp Esthetic

    FDA UDI
    Harvest Dental Products, LLC·D87010036201·Temp Esthetic Disc, 98.5 X 20mm, Shade A1

    LIFEPAK® 12 defibrillator/monitor

    FDA UDI
    PHYSIO-CONTROL, INC.·00885074916729·LP12AABCABAACAABAAAAAAAALP12 MONITOR-DEFIB

    SCANLAN® Titanium Clamp

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159035452·SCANLAN® Titanium Clamp

    SCANLAN® Titanium Clamp

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159035438·SCANLAN® Titanium Clamp

    SCANLAN® Titanium Clamp

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159035445·SCANLAN® Titanium Clamp

    SCANLAN® Titanium Clamp

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159035469·SCANLAN® Titanium Clamp

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 6, 2014

    METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PBN FALLOPIAN TUBE CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MAINTENANCE STATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code DZI·February 28, 2013

    ISOLA ROD

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code MNH·February 23, 2011

    ECHELON 60 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDW·February 15, 2008

    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