17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Invacare AVIVA Storm RX Power Chair
FDA 510(k)
FDA Class 2
·Physical Medicine
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM
LTF-Y0009; MAJ-YOO41; XOEV-3D1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M2A 28MM RINGLOC LINER
FDA 510(k)
FDA Class 3
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 4, 2011
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·September 15, 2014
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·June 6, 2023
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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