13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BABI*PLUS BUBBLE PAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776402891·Elevator #15 6" (15cm)
Mictec Flexible Trocar Set
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111400·Mictec Flexible Trocar Set Black Plastic Fixati...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028695·
Mictec Flexible Trocar Set
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111417·Mictec Flexible Trocar Set Black Plastic Fixati...
AV 800 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
CADENCE PHYSIO QC ADULT RTS
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MLN·April 18, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·February 1, 2015
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026