8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TECHNICARE 248 SL & 260SL
FDA 510(k)
FDA Class 2
·Radiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 2, 2012
REFURBISHED RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·March 12, 2014
ITREL 3
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·September 23, 2010
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018