8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA UDI
GSOURCE LLC·00840314245946·Drill Sleeve Dbl 120mm 1.1/1.5mm
AMS 800 URINARY CONTROL SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZY·May 18, 2019
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
FDA Enforcement
Class III
·Terminated·Technidata S.A.·July 24, 2013
Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
FDA Recall
Terminated
·Misys Healthcare Systems·Product code JQP·January 17, 2003
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·April 22, 2020
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
FDA Recall
Terminated
·Technidata S.A. 387, Avenue Jean Kuntzmannn Montbonnot St Martin France·Product code JQP·June 20, 2013
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code LXG·March 9, 2020
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
FDA Recall
Terminated
·Hamilton Co·Product code JJE·September 26, 2011