15 results · 19ms · Sources: EU EUDAMED, US FDA

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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