13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Radixact Treatment Delivery System
FDA 510(k)
FDA Class 2
·Radiology
SBI ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
WATER BOTTLE CAP SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HAMILTON-T1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·April 2, 2026
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
HAMILTON-T1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·March 31, 2026
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
LANCET DEVICE MMT-395 QCKSRTR M4 13L
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code KZH·July 8, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018