BEUDAMED
    38 results · 17ms · Sources: EU EUDAMED, US FDA

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    VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LPH·November 29, 2017

    VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Segmental fluted stem, 18x250mm bwd, Sterile,

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 18x250mm bwd, Sterile,

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·March 27, 2013

    Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code NDP·March 11, 2013

    VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LPH·November 29, 2017

    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LPH·November 29, 2017

    Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·February 26, 2020

    S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***". The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer.

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code IYN·March 27, 2011