99 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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VidiStar(TM) PACS & DICOM Viewer Software system
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corp Informatics Division·September 12, 2018
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·April 17, 2013
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592
FDA Recall
Terminated
·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592
FDA Recall
Terminated
·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004
VidiStar(TM) PACS & DICOM Viewer Software system
FDA Recall
Terminated
·Hitachi Healthcare Americas Corp Informatics Division·Product code DQK·August 28, 2018
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·March 15, 2013
Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
FDA Recall
Terminated
·Picis Inc.·Product code NSX·August 12, 2011
MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
FDA Recall
Terminated
·Dade Behring·Product code LON·February 7, 2005
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 28, 2021
Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
FDA Recall
Terminated
·Dade Behring, Inc.·Product code LIE·September 27, 2006
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 4, 2012
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
FDA Recall
Terminated
·Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom·Product code NXT·July 14, 2021
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
FDA Recall
Terminated
·Dade Behring, Inc.·Product code JJE·July 3, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007