13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130530·Screw - Ø1.9 mm x 8 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813053CP1·Screw - Ø1.9 mm x 8 mm
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30, SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code MNS·September 13, 2023
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2010
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015