20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MPS 3 Myocardial Protection System
FDA 510(k)
FDA Class 2
·Cardiovascular
Intraoral Scan Body 3.0
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075182·
CORFLO Controller
FDA UDI
CORPAK MEDSYSTEMS, INC.·10815149022922·Feeding tube , 7 g weighted, with stylet
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770456157·CORFLO* Nasogastric/Nasointestinal Feeding Tube...
Halyard
FDA UDI
Avanos Medical, Inc.·10680651456158·HALYARD* CORFLO* Nasogastric/Nasointestinal Fee...
SAS VALUE HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
FDA 510(k)
FDA Class 2
·General Hospital
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 13, 2024
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·July 1, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2017
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014