15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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World Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
FDA 510(k)
FDA Class 2
·General Hospital
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESSURE
FDA Adverse Event
Other
·Product code HHS·February 26, 2007
GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013
EUFLEXXA
FDA Adverse Event
Injury
·BIO-TECHNOLOGY GEN (ISRAEL) LTD·Product code MOZ·July 20, 2011
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·November 4, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·July 12, 2013
MICROGARD II BACT/VIRAL FILTER
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL GMBH·Product code CAH·June 19, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018