20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OHC COVID-19 Antigen Self Test
FDA 510(k)
FDA Class 2
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707040408·DB BRACKETS 22 T-7 A+11 BH CUS U/L
LEONE SPA
FDA UDI
LEONE SPA·08033707040415·DB BRACKETS 22 T-11 A+5 BH CUS L/R
Portex
FDA UDI
ICU MEDICAL, INC.·15019517084320·
STABIL-O-GRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 19, 2024
CD HORIZON SOLERA 5.5/6.0
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·August 7, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·April 1, 2026
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 2, 2013
EXCOR BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·November 10, 2014
POSEY SITTER II ALARM
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·September 2, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·July 22, 2013
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·September 25, 2025
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
CD HORIZON SOLERA 5.5/6.0
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·June 20, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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