89 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
FDA Recall
Terminated
·Molded Products Inc·Product code FPA·June 10, 2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·May 10, 2019
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·April 10, 2018
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·April 10, 2018
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
FDA Recall
Terminated
·Trilliant Surgical, LLC·Product code HTW·October 10, 2019
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
FDA Recall
Terminated
·Exactech, Inc.·Product code LRN·September 10, 2019
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
FDA Recall
Terminated
·Cadence Science, Inc.·Product code FMF·May 10, 2019
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
FDA Recall
Terminated
·InfuTronix LLC·Product code FRN·May 28, 2019
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JQP·February 21, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
FDA Recall
Terminated
·Alto Development Corp·Product code JDQ·September 10, 2019
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Recall
Terminated
·Biocare Medical, LLC·Product code NJT·October 10, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
FDA Recall
Terminated
·Alto Development Corp·Product code JDQ·September 10, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
FDA Recall
Terminated
·Alto Development Corp·Product code JDQ·September 10, 2019
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
FDA Recall
Terminated
·Alto Development Corp·Product code JDQ·September 10, 2019
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
FDA Recall
Terminated
·QUIDEL CARDIOVASCULAR INC·Product code DIF·April 9, 2019