27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
PHILIPS
FDA UDI
Respironics California, Inc.·00884838009844·V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053613·MICROMASSAGE ARMBANDS CCL1, SIZE M, FUCSIA, GRA...
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037300275·HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCRE...
SOFT PLUG ABSORBABLE PLUG-SA
FDA 510(k)
FDA Unclassified
·Unknown
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
FDA 510(k)
FDA Class 2
·Radiology
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·January 20, 2026
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
ENTERRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·March 1, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 23, 2008
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·September 11, 2019
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
FDA Enforcement
Class II
·Ongoing·Respironics California, LLC·February 19, 2020
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
FDA Enforcement
Class I
·Ongoing·Respironics California, LLC·April 27, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·February 28, 2022
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·November 2, 2020
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
FDA Recall
Terminated
·Respironics California Inc·Product code MNT·April 24, 2017
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Ongoing·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
FDA Enforcement
Class I
·Terminated·Respironics California Inc·May 24, 2017