278 results
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56ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·July 29, 2022
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·March 8, 2018
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC
FDA Adverse Event
Malfunction
·B. BRAUN AVITUM AG - MELSUNGEN·Product code FKJ·January 5, 2016
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
FDA Recall
Terminated
·TEM Systems Inc·Product code JPA·September 13, 2016
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
FDA Recall
Terminated
·TEM Systems Inc·Product code GGN·February 18, 2016
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
FDA Recall
Terminated
·TEM Systems Inc·Product code JPA·October 23, 2014
TPW 24IN 2-0 D/A RB-1,SKS BWY
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code LDF·October 1, 2021
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
FDA Enforcement
Class II
·Terminated·TEM Systems Inc·November 2, 2016
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
FDA Enforcement
Class II
·Terminated·TEM Systems Inc·April 15, 2015
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
FDA Enforcement
Class II
·Terminated·TEM Systems Inc·March 16, 2016
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085024042·NAC-PAC EA3 (2.5%) tray w/ NALC powder
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020938·NAC-PAC RED (3.0%) 5x50ml
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020549·Nocardia Stain Control Slides
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022222·NALC Ampules 5x250mg
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020273·NAC-PAC N30 Tray
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085024035·0.9% Saline 4.0ml
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020389·CELL-BOND Slides, 1 Well, black background
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020716·M/15 Phosphate Buffer 250ml bottle
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085022253·ETM (micro) bag kit
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085023533·TB Fluorescent Decolorizer 8x250ml