BEUDAMED
    132 results · 19ms · Sources: EU EUDAMED, US FDA

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    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

    FDA Recall
    Open, Classified ·MicroPort Orthopedics Inc.·Product code LWJ·July 31, 2020

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    FDA Recall
    Open, Classified ·Edge Biologicals Inc·Product code QMC·October 2, 2023

    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·November 24, 2020

    Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code LNH·September 19, 2008

    Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Recall
    Completed ·Smiths Medical ASD, Inc.·Product code FMI·November 21, 2014

    RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024

    Sterile Nail Clipper Concave Edge (67710)

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code PWC·March 29, 2019

    CEI Cutting Edge Instruments (PTC-57C)

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJL·October 20, 2020

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·June 22, 2020

    Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Recall
    Completed ·Smiths Medical ASD, Inc.·Product code FMI·November 21, 2014

    Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Recall
    Completed ·Smiths Medical ASD, Inc.·Product code FMI·November 21, 2014

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021

    Biograph mCT Flow Edge-4R, Model Number 10528955

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

    SOMATOM Definition Edge -Computed tomography system Model 10590000

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021

    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·August 30, 2021