17 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APTUS® Coronoid 2.0
FDA 510(k)
FDA Class 2
·Orthopedic
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
FDA 510(k)
FDA Class 2
·Radiology
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066225·Corpectomy, 16Dx18Wx61H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066539·Corpectomy, 16Dx18Wx61H 6°
LINER: MPACT FLAT PE HC LINER Ø40/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 23, 2019
STEM: AMISTEM HA COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2019
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 10, 2014
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWL·June 6, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 6, 2019
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·February 26, 2019
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·June 20, 2019
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
FDA Enforcement
Class III
·Terminated·ECOLAB INC·July 11, 2018
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
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