10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULARIS VARIOSTAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATH LAB KIT
FDA Adverse Event
Malfunction
·ICU MEDICAL INC.·Product code DQO·October 3, 2017
BELMONT UNIT, MODEL 2000 SERIES
FDA 510(k)
FDA Class 1
·Dental
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·LEE LABORATORIES, INC.·Product code MDB·January 21, 2022
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 22, 2013
MP30 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·April 15, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 9, 2008
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024