BEUDAMED
    45 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 ×

    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·January 11, 2017

    Airway Mobilescope MAF-TM

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Airway Mobilescope MAF-TM

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 10, 2018

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012

    COBAS TaqMan analyzer, Series 96; catalog number 8080216.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·March 6, 2003

    POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Cytomics FC500 with CXP Software

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JJF·November 23, 2005

    Voyager RX Coronary Dilatation Catheter

    FDA Recall
    Terminated ·Guidant Corporation Advanced CardiovascularSystem·Product code MAF·January 27, 2005

    COBAS TaqMan 48 Analyzers.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·May 24, 2004

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·January 14, 2020

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

    FDA Recall
    Terminated ·Guidant Corporation ACS·Product code MAF·May 7, 2003

    CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.

    FDA Recall
    Terminated ·Numed Inc·Product code MAF·June 26, 2003

    BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

    FDA Recall
    Terminated ·Abbott Vascular Devices·Product code MAF·July 21, 2003

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·April 24, 2012

    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code EJF·February 8, 2013

    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code MAF·October 24, 2019

    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJF·February 1, 2012

    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

    FDA Recall
    Terminated ·Product code MAF·March 20, 2003