20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PIVO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEONE SPA
FDA UDI
LEONE SPA·08033707065685·INTRAORAL ELASTICS 4,5 oz 1/8" brown
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741610·Pynchon Suction Tube 11" (27.5cm), tip with lar...
OTIS -C PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
VBB SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip Catheter
FDA UDI
Unisensor AG·07640172971345·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973639·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971338·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973219·
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·Product code BTT·May 18, 2020
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·October 3, 2008
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·June 13, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 27, 2011
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
FDA Enforcement
Class II
·Terminated·Merits Holdings Co. dba Merits Health Products, Inc.·April 8, 2020
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025