15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JULIET LL
FDA 510(k)
FDA Class 2
·Orthopedic
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015855·Full Radius Resector 3,5
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046459·PrimaLIF LLIF PEEK Implant, 11mm X 26mm X 35mm,...
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 25, 2002
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·October 12, 1999
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·June 22, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 3, 2014
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·May 9, 2022
VIDAS TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 25, 2020
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·August 19, 2021
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019