243 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PBP TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Z Liquid HT OM2-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122158·Dental porcelain/ceramic restoration kit
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032683·BASIN SET
SIGMA STERILIZATION POUCH & ROLL
FDA 510(k)
FDA Class 2
·General Hospital
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRASAFE X100L PNG CLEAR NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·February 5, 2021
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·February 10, 2020
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·May 17, 2013
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·September 26, 2014
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 13, 2011
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2016
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·January 26, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·July 26, 2019
BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·September 19, 2018
ULTRASAFE X100L PNG CLEAR NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·March 19, 2019
BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·February 27, 2020