14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hi-Torque Command 18 Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
External Fixation
FDA UDI
Life Spine, Inc.·00190837033996·Tube Wrench
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
FDA 510(k)
FDA Class 2
·General Hospital
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Widex
FDA UDI
Widex A/S·05706069792683·Widex UNIQUE U-PA (Titan grey ) 30, RC coil
Widex
FDA UDI
Widex A/S·05706069819380·Widex UNIQUE U-FS (Titan grey ) 30, Telecoil, R...
PLUM XLD 110V L.A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 11, 2013
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·September 23, 2008
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 21, 2011
Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
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