BEUDAMED
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    PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197055505·Faure Perritoneal Clamp Forceps Fig. 1 1x2 te...

    COLTOLUX LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    ORLOCATE SYSTEM MODEL ORL 100

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BD ULTRASAFE PLUS¿ X100L PNG CLEAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON HUNGARY KFT (BD)·Product code FMI·November 7, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 31, 2013

    GLUCO-QUANT GLUCOSE/HK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFR·June 27, 2011

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 28, 2008

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022