18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALP 501 RB PUMP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097829·DISTRACTOR 9112311 SGL BARREL 16/10MM OS
23mm x 10mm x 11mm PLIF with Inserter
FDA UDI
XENCO MEDICAL LLC·B064XM01123111·23mm x 10mm x 11mm PLIF with Inserter
23mm x 10mm x 11mm Titanium PLIF with Inserter
FDA UDI
XENCO MEDICAL LLC·B064XMTL1112311·
23mm x 10mm x 11mm Titanium PLIF with Inserter (Pack of 2)
FDA UDI
XENCO MEDICAL LLC·B064XMTL11123112·
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 15, 2022
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 11, 2009
BECKMAN COULTER AU640 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·May 24, 2011
BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 2, 2022
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 20, 2022
ADVIA CENTAUR XP BR (27.29)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC·Product code MOI·May 14, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
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
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025