20 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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THYRETAIN TM TSI REPORTER BIOASSAY
FDA 510(k)
FDA Class 2
·Immunology
WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
FDA 510(k)
FDA Class 2
·General Hospital
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2020
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 15, 2021
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 3, 2013
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 5, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018