7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NITI COIL SPRINGS
FDA 510(k)
FDA Class 1
·Dental
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
FDA 510(k)
FDA Class 2
·Radiology
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·January 29, 2013
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 2, 2010
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024