24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTABLE VENTILATOR, MODEL EPV-100
FDA 510(k)
FDA Class 2
·Anesthesiology
TRUMPF MEDICAL
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761979338·OR table top Carbon Spine
TS 7500
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968646·OR table top Carbon Spine
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049798·Channel Drain, 10mm Flat Full Fluted
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021689·
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·January 29, 2014
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·January 29, 2014
SINUSCOPE AND BACCESSORIES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CRYOPEN AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Crescendo Meniscal Insert CR Ultracongruent 12mm Size 4
FDA UDI
AMPLITUDE SAS·03701089524766·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·January 25, 2013
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·January 25, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 28, 2011
DEXATIP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 15, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 19, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 13, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·October 3, 2024