31 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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Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
FDA Recall
Terminated
·Stryker Spine·Product code LHX·January 18, 2010
Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8
FDA Recall
Terminated
·Nebion, LLC·June 25, 2008
Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code MPB·December 2, 2003
Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code MPB·December 2, 2003
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code LJS·April 27, 2005
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
FDA Enforcement
Class II
·Terminated·Stryker Spine·October 17, 2018
NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 13, 2019
Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 28, 2011
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
FDA Recall
Terminated
·Beckman Coulter Inc·Product code DHX·April 12, 2006
IMMULITE /IMMULITE 1000 CEA
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
FDA Recall
Terminated
·Diagnostic Products Corp·Product code DHX·May 26, 2005
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code JHX·April 3, 2006
CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
FDA Recall
Terminated
·BioCheck Inc·Product code DHX·December 22, 2010
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JHX·November 11, 2015
IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012
IMMULITE 2000/IMMULITE 2000 XPi CEA
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018
IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JHX·November 11, 2015
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DHX·October 13, 2015
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DHX·March 5, 2018