12 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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ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131255709·SENSEI, BTE 312 WL 75 DBL
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA 510(k)
FDA Class 2
·General Hospital
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 19, 2014
DPM 6/7 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·May 23, 2013
HICKMAN 7 FR DUAL-LUMEN CV CATHETER
FDA Adverse Event
BARD ACCESS SYSTEMS·Product code LJS·August 15, 2014
VITA 2
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·June 16, 2011
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015