14 results · 21ms · Sources: EU EUDAMED, 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