7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
DRYVIEW CHROMA IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
STIMCARE CARBON FOAM 2 INCH X 2 INCH SQUARE, 4 PACK
FDA Adverse Event
Injury
·EMPI, INC·Product code GXY·June 2, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022