10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PENTAX Medical Video Esophagoscope EE17-J10
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VERSANT VALUE
FDA UDI
FGX INTERNATIONAL INC.·00193033307700·
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113721·CYSTOTOME CURVED 27GA
VASHE WOUND THERAPY SOLUTION
FDA 510(k)
FDA Unclassified
·Unknown
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·November 4, 2014
MEDICHOICE WARM PACK
FDA Adverse Event
Other
·COLDSTAR INTL INC·Product code IMD·August 21, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
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