20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RP CUTTING NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327177534·DELTA 1.7MM 3X21 HYBRID CNTRSINKS 0.5MM
8100/8500 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AMT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 9, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·September 26, 2018
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 10, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 30, 2019
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 3, 2013
SULTRASONIC GENERATOR
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·August 21, 2014
CARPENTIER-EDWARDS® PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 18, 2011
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 12, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·December 21, 2021
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 20, 2023
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 3, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 3, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 19, 2019
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 5, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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