31 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRILLIANT SURGICAL SUBTALAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AKLARUS PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OYC·September 18, 2019
1823260-2015-04249
FDA Adverse Event
Malfunction
·September 30, 2015
1823260-2015-03867
FDA Adverse Event
Malfunction
·July 27, 2015
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 30, 2015
1823260-2015-06132
FDA Adverse Event
Malfunction
·December 28, 2015
1823260-2015-03937
FDA Adverse Event
Malfunction
·August 12, 2015
COBAS E411 RACK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2015
1823260-2015-03563
FDA Adverse Event
Malfunction
·June 1, 2015
ARCHITECT CA 15-3
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MOI·October 3, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
SCRDRIVERSHAFT T25 F/URS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 21, 2013
FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W
FDA Adverse Event
Death
·FUJIFILM CORPORATION·Product code FDA·January 26, 2024
1823260-2015-03804
FDA Adverse Event
Malfunction
·July 15, 2015
COBAS 8000 E602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 10, 2015
1823260-2015-03580
FDA Adverse Event
Malfunction
·June 4, 2015
1823260-2015-03666
FDA Adverse Event
Malfunction
·June 17, 2015
1823260-2015-04332
FDA Adverse Event
Malfunction
·October 14, 2015