BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821601470·SCISSORS, SURGICAL TISSUE, DENTAL

    Dry Acid Dissolution Unit

    FDA UDI
    Fresenius Usa, Inc.·00840861100996·132 Gallon

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486020224·MCK FEMORAL TEMPLATE (SIZE 7 LM/RL)

    Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 23, 2015

    Denovo general purpose dental molar band

    FDA UDI
    Denovo Dental, Inc.·00810059290013·Denovo general purpose dental molar band - Maxi...

    Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·November 25, 2015

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962154496·SILICONE BIPOLAR CABLE

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·June 27, 2011

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 13, 2017

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 13, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    TFNA FEM NAIL Ø10 R 125° L320 TIMO15

    FDA Adverse Event
    Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018

    10MM/125 DEG TI CANN TFNA 200MM - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·March 31, 2022

    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015