10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ARIES GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190592·Bone File Rasp
ORTHOLOC(TM) BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·September 15, 2008
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·April 29, 2022
Access Immunoassay Systems Free T4, Part Number: 33880
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·March 24, 2010