235 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·April 17, 2013
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZD·March 8, 2013
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Enforcement
Class II
·Terminated·Molnlycke Health Care, Inc·May 8, 2019
Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·December 29, 2009
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·July 18, 2014
Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·September 8, 2003
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated differential cell counter; Part Number 774178; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user, Automated differential cell counter; Part Number 722396; Beckman Coulter; Miami, FL 33196.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·May 4, 2007
Unicel DxH 800 Coulter Cellular Analysis System
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·February 12, 2010
Coulter LH 700 Series Hematology Analyzers
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·January 10, 2003
Abbott CELL-DYN 3500 Hematology Analyzer
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·May 11, 2007
COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·February 23, 2011
Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·March 27, 2009
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·March 15, 2011
COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. Serial Number: all. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·December 1, 2011
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Recall
Terminated
·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020