8 results
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17ms
·
Sources: EU EUDAMED, US FDA
IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
FDA 510(k)
FDA Unclassified
·Unknown
JOBST Relief
FDA UDI
BSN MEDICAL, INC.·04042809690637·RELIEF 20-30 MM HG THIGH W/DOT BAND OPEN TOE EX...
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 11, 2014
EPOCH XP
FDA Adverse Event
AXON SYSTEMS·Product code GWE·September 28, 2010
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·September 30, 2010
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006