BEUDAMED
    23 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    FDA Recall
    Terminated ·Hitachi America, Ltd., Power Systems Division·Product code LHN·April 15, 2019

    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KRR·July 30, 2014

    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

    CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRR·January 11, 2016

    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HRY·December 21, 2017

    Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209. The product is an oscillating cutting device used for cutting bone and bone related tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207. The product is a linear cutting device used for cutting bone and bone related tissue including the sternum.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208. Note: The product label declares the product to be a handpiece. The product is an oscillating cutting device used for cutting bone and bone related tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6206. Product is a linear cutting device used for cutting bone and bone related tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4. The product is an oscillating cutting device used for cutting bone and bone related tissue.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIJ·October 10, 2008

    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CIJ·July 10, 2020