10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Rebellion; Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038646·
ATELLICA CH CALCIUM_2 (CA_2)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CIC·September 14, 2023
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
FDA 510(k)
FDA Class 2
·Neurology
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
FDA 510(k)
FDA Class 2
·Radiology
VAPR3 GENERATOR *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·September 24, 2019
BED, HOSPITAL
FDA Adverse Event
Other
·JOERNS HEALTHCARE, INC.·Product code FNJ·November 3, 2008
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 21, 2011
ZIMMER MMC CUP 58MM/50MM CODE P
FDA Adverse Event
Other
·ZIMMER GMBH·Product code JDI·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025