16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
Orthos
FDA UDI
ORMCO CORPORATION·00889989053425·U6R SL B/T ORTHOS 22 FLG -10/0/10
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753473539·
Symmetry Deschamps
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482041444·Symmetry® Carrier, Desch Ligature, Blunt Right,...
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·December 14, 2016
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·February 3, 2017
HUDSON SILENT HUMIDIFIER ADAPTOR
FDA Adverse Event
Malfunction
·TELEFELX MEDICAL·Product code BTT·May 23, 2013
GENTLEPOWER LUX CONTRA ANGLE 25LPA
FDA Adverse Event
KAVO DENTAL GMBH·Product code EFB·September 17, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·March 10, 2017
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
Epidural Tray Catalog 1307
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026