382 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·July 10, 2017
ARRITECHNO/PHILIPS XRAY SYSTEM
FDA Adverse Event
Injury
·PHILLIPS MEDICAL SYSTEMS·Product code IXX·February 18, 1998
STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code GGN·August 23, 2011
Processor, Cine Film
FDA classification
FDA Class 2
·Processor, Cine Film
IOX CO. LTD.
FDA registration
IOX CO. LTD.·3 products·🇯🇵 Japan
CMFlex
FDA UDI
Dimension INX Corp·00860009902008·CMFlex Block for bone graft 38 x 38 x 9 (mm)
N1101 Nexus Ligator 5 Pack
FDA UDI
INX MEDICAL, LLC·00861815000469·The inx Medical Nexus Hemorrhoid Ligator is a s...
Nexus Hemorroid Ligator
FDA UDI
INX MEDICAL, LLC·00861815000414·The inx Medical Nexus™ Hemorrhoid Ligator is a ...
N1101 Nexus Ligator 1 Pack
FDA UDI
INX MEDICAL, LLC·00861815000476·The inx Medical Nexus Hemorrhoid Ligator is a s...
Prismaflex
FDA UDI
GAMBRO AB·07332414105266·The Prismaflex control unit is a software contr...
Cornerstones4Care® Powered by Glooko Mobile Application
FDA UDI
GLOOKO, INC.·00855093008040·Cornerstones4Care® Powered by Glooko Mobile App...
Nonin
FDA UDI
NONIN MEDICAL, INC.·00849686070620·Intermediate Cable
Glooko Mobile Application
FDA UDI
GLOOKO, INC.·00855093008033·The Glooko Mobile application for iOS and Andro...
Nexxis OR
FDA UDI
Barco NV·05415334025233·Nexxis Management Suite
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X-SMART W/CONTRA ANGLE EUR
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·February 1, 2022
X-SMART W/CONTRA ANGLE EUR
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKX·March 30, 2023
X-SMART PLUS
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·January 24, 2023
KALIX II IMPLANT, MODEL 141 0XX WITH XX
FDA 510(k)
FDA Class 2
·Orthopedic
X-SMART PLUS
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·December 7, 2021