BEUDAMED
    166 results · 11ms · 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 Status: Terminated ×

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Tornier, Inc·Product code HSB·June 25, 2015

    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·October 15, 2014

    DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG. The device is used in the treatment of fractures and osteotomies of the distal radius.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HRS·December 23, 2008

    Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Recall
    Terminated ·Cook Inc.·Product code MQF·December 19, 2017

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·August 5, 2015

    Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KLI·August 26, 2010

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·August 20, 2014

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRS·June 23, 2014

    Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 30, 2004

    Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.

    FDA Recall
    Terminated ·Novoste Corporation·Product code JAJ·January 25, 2002

    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

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    FDA Recall
    Terminated ·Conformis, Inc.·Product code JWH·July 20, 2020

    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·November 19, 2014

    MaxTorque Cannulated Screw Model # MSD-010-55-060S

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HWC·April 7, 2009

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·September 2, 2020

    Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601

    FDA Recall
    Terminated ·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004

    Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018