18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IC-WHCD100 (Inspire)
FDA 510(k)
FDA Class 2
·Dental
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 20, 2019
UBM PLUS
FDA 510(k)
FDA Class 2
·Radiology
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E-Z CLEAN NEEDLE MOD 2.75IN
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·September 14, 2018
E-Z CLEAN BLADE 2.5IN
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·September 14, 2018
COVIDIEN ELECTROSURGICAL GENERATOR
FDA Adverse Event
Injury
·COVIDIEN / MEDTRONIC, INC.·Product code GEI·August 9, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020