188 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capital
FDA UDI
COLLEGE PARK INDUSTRIES, INC.·00195411108381·Knee Pad Replacement Kit, Jet Black
COMPRESSOR
FDA Adverse Event
Malfunction
·KOBELCO NORTHWEST·Product code KPJ·August 25, 1997
NUMOBAG
FDA Adverse Event
Injury
·NUMOTECH, INC.·Product code KPJ·November 13, 2001
BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 11, 2021
VCL RAP CT BRD UD 27IN 3-0 S/A FS-1
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·April 8, 2026
VCL RAP CT BRD UD 27IN 3-0 S/A FS-1
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·April 8, 2026
VCL RAP CT BRD UD 27IN 3-0 S/A FS-1
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·April 8, 2026
VCL RAP CT BRD UD 27IN 3-0 S/A FS-1
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·April 8, 2026
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·March 24, 2006
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
Chamber, Oxygen, Topical, Extremity
FDA classification
FDA Class 2
·Chamber, Oxygen, Topical, Extremity
KP3
FDA UDI
Quality Aspirators, Inc.·00814005023243·KP3
KP2
FDA UDI
Quality Aspirators, Inc.·00814005023236·KP2
ANTAR SP. J.
FDA registration
ANTAR SP. J.·9 products·🇵🇱 Poland
DBM Putty 5.0ccJar
FDA UDI
Xtant Medical Holdings, Inc.·00849777009386·ONE (1) PACKAGE - CONTAINING 5.0cc
DBM Putty 1.0cc Jar
FDA UDI
Xtant Medical Holdings, Inc.·00849777008501·ONE (1) PACKAGED - CONTAINING 1.0cc
KTJ DENTAL LAB INC
FDA registration
KTJ DENTAL LAB INC·10 products·🇺🇸 United States
CD68 [KP1]
FDA UDI
BIOCARE MEDICAL LLC·00847627036735·
CD68 [KP1]
FDA UDI
BIOCARE MEDICAL LLC·00847627005632·
CD68 [KP1]
FDA UDI
BIOCARE MEDICAL LLC·00847627023896·