7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STAR CALC
FDA 510(k)
FDA Class 2
·Anesthesiology
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN M2A HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 16, 2014
CORAIL2 STD SIZE 11
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 17, 2012
VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DWF·June 25, 2015
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