18 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive® CoRoent® Small Interlock System
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138142·Trial, 42 X 32, 19mm Height 22° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138159·Trial, 42 X 32, 21mm Height 22° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138128·Trial, 42 X 32, 15mm Height 22° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138135·Trial, 42 X 32, 17mm Height 22° Hyperlordotic
PULSE OXIMETER, MODEL PM-50
FDA 510(k)
FDA Class 2
·Cardiovascular
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LJK·August 8, 2011
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LJK·October 4, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2011
FMsealer Open Shears. Model FM3001
FDA Enforcement
Class II
·Terminated·Domain Surgical, Inc.·December 7, 2016
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025