68 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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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
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
IMMULITE 2000/IMMULITE 2000 XPi CEA
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018
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
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DHX·December 3, 2003
Immulite 1000 CEA Catalog No. LKCE1
FDA Recall
Terminated
·Diagnostic Products Corp·Product code DHX·May 3, 2004
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·April 30, 2014
DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
FDA Recall
Terminated
·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·December 4, 2014
DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
FDA Enforcement
Class II
·Terminated·Musculoskeletal Transplant Foundation, Inc.·April 29, 2015
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
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
FDA Recall
Terminated
·Pro-Dex Inc·Product code GEY·September 25, 2018
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015