BEUDAMED
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    LED Light Therapy Device, KN-7000L

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD Difco™ Salmonella H Antiserum r

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902227519·BD Difco™ Salmonella H Antiserum r, 3 mL

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111190094·QUIMBY GUM SCISSORS CVD 5"

    TandemHeart Pump and Escort Controller

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IMP,TSV,4.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 28, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014

    15X100MM KII OPTICAL ACCESS SYSTEM NON-THREADED

    FDA Adverse Event
    Other ·APPLIED MEDICAL·Product code GCJ·July 26, 2011

    11.0MM TI HELICAL BLADE 105MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·July 12, 2013

    Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·March 28, 2008

    Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·December 20, 2004

    Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·December 8, 2004

    LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·March 29, 2011

    LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·August 15, 2011

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018