15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HELIODENT MD
FDA 510(k)
FDA Class 2
·Dental
VENTRIO
FDA UDI
Davol Inc.·00801741031526·Ventrio ST Hernia Patch, 8.0 cm x 12.0 cm (3.1"...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013981·Range Of Motion (ROM) Hinged Knee, XX-Large
Posicast Thermoplastic
FDA UDI
MEDTEC, INC.·10841439101800·Disposable non-sterile LPR3 Posicast Microperfo...
Barco
FDA UDI
Barco NV·05415334002968·MDRC-1219 HB
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTICOAT MOISTURE CONTROL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 8, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·December 7, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
VENTRIO ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 6, 2018
VENTRIO ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 18, 2018
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Enforcement
Class II
·Terminated·Superstat Corp·November 28, 2012
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
FDA Recall
Terminated
·Superstat Corp·Product code LMF·October 24, 2012