15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070399·BE YOU ICON CURVY, SIZE M-XL, BLU NAVY, GRADUAT...
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
FDA 510(k)
FDA Unclassified
·Unknown
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·Product code LGW·November 2, 2021
RINGLOC RIMCUP SHELL
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017
ASR TAP SLV ADAP 12/14 -1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016
MIH MOD CUP INSERTER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·April 17, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 18, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·June 30, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022