65 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Recall
Terminated
·Abbott Laboratories·Product code NIG·May 30, 2012
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·July 4, 2012
Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden
FDA Recall
Terminated
·Stille AB Gardsvagen·Product code IXR·August 27, 2008
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
FDA Recall
Terminated
·Medical Positioning Inc·Product code IXR·February 1, 2010
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IXR·February 6, 2017
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OAR·February 13, 2020
Philips Easy Diagnost X-Ray System
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXR·July 23, 2007
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IXR·July 11, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
UroDiagnost; x-ray system. Product Code: 708033
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code IXR·July 19, 2016
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code IXR·March 26, 2018
Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
FDA Recall
Terminated
·GE Healthcare·Product code IXR·January 2, 2008
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
UroDiagnost Eleva, system code 708033
FDA Recall
Terminated
·Philips North America, LLC·Product code IXR·December 30, 2019