BEUDAMED
    233 results · 33ms · Sources: EU EUDAMED, US FDA

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    ADT MINI PERITONEAL LAVAGE KIT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007302·AcQMap Auxiliary Interface Box

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551201350·VOLKMANN Retractor, 2 prongs

    ACUMED

    FDA UDI
    Acumed LLC·10806378042065·Ulnar Shortening Reduction Peg

    CONTEC STERILE GLOVES

    FDA Adverse Event
    Malfunction ·CONTEC, INC.·Product code LZC·May 16, 2024

    S57D DIGITAL OPERATING ROOM CAMERA

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

    5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·April 3, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

    regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·April 24, 2014

    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

    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FIK·April 3, 2014

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code KDI·May 21, 2013

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code KDJ·October 6, 2015

    GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.

    FDA Recall
    Terminated ·ConvaTec·Product code EXB·March 7, 2008

    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    FDA Recall
    Open, Classified ·T.G. Eakin Limited·Product code EXE·August 8, 2024

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KPE·July 27, 2017