12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI
FDA 510(k)
FDA Class 2
·General Hospital
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 22x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015712·The NYOrtho APEX CORE Gel-Foam Cushion combines...
CAPTURE-R READY-SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 26, 2016
NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 22x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015750·Designed to remove pressure from the coccyx, th...
NYOrtho Wheelchair Cushion Gel-Foam 22x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677017846·NYOrtho Gel-Foam Cushions combine a dual chambe...
NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 22x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015774·For patients requiring hip positioning and to e...
NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 22x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015804·For patients requiring hip positioning, the NYO...
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DRE·August 19, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 19, 2008
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·July 1, 2013