13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ROKI Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Richard Wolf GmbH·04055207014424·BRONCHOSCOPE-TUBE ID 9.5MM model Hemer, OD 10....
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114307·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 S...
NOVOFINE 8MM (30G)
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMI·May 1, 2002
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Nerve and Muscle Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 24, 2024
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 30, 2014
3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S.
FDA Adverse Event
Other
·3M ESPE DENTAL PRODUCTS·Product code NOF·July 20, 2011
GENTLECATH INTERMITTENT URINARY CATHETER
FDA Adverse Event
Other
·CONVATEC·Product code KOD·July 3, 2013
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021