11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BRUCELLA AGAR
FDA 510(k)
FDA Class 1
·Microbiology
ERA® Standard IA Male Package (5)
FDA UDI
STERNGOLD DENTAL LLC·00841549101052·Attachments are two-part connectors. One part ...
AURADONICS
FDA UDI
AURADONICS INC.·00810033835773·EXTRAORAL LATEX ELASTICS 1/2" 16 oz. - AMBER, 1...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41428111280·Titanium TLIF Spacer, 28 x 11 x 12mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40428111280·PEEK TLIF Spacer, 28 x 11 x 12mm, 8 deg
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LABONACHECK A1C
FDA 510(k)
FDA Class 2
·Hematology
PLM A+ SPANISH DEVIC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 24, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 13, 2010
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024