20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARROW REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231121930·Harms-Colibri Forceps 1x2 teeth, Angled 45 degr...
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
FDA 510(k)
FDA Class 2
·Cardiovascular
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·October 3, 2016
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 3, 2011
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 14, 2020
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 14, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Model Number L131, ESSENTIO DR EL 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