305 results
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22ms
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Sources: EU EUDAMED, US FDA
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Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
FDA Recall
Open, Classified
·The See Clear Company·Product code LPL·January 6, 2017
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
FDA Recall
Open, Classified
·Maquet Medical Systems USA·Product code DTZ·May 18, 2023
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWE·February 23, 2011
MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
FDA Recall
Terminated
·Maquet Inc.·Product code DWE·September 7, 2010
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
FDA Recall
Terminated
·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013
Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 4901 Material: 701050839
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019