8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
FDA 510(k)
FDA Class 2
·Dental
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRAXX NEPHROSTOMY BALLOON AND SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJE·August 8, 2024
DEPUY
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC·Product code KWA·July 22, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·June 6, 2013
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·September 30, 2008
INNOVA IGS 530
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019