11 results
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19ms
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Sources: EU EUDAMED, US FDA
GENERAL UTILITY SURG. SCISSORS #460180-
FDA 510(k)
FDA Class 1
·Orthopedic
ACUMED
FDA UDI
Acumed LLC·10806378044243·KickStand Post 20°
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Endo-Model Saddle Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575047796·Base components with inside anti-rotation pin, ...
ETHICON SUTURE MATERIAL
FDA Adverse Event
Malfunction
·ETHICON·Product code HAS·September 6, 2007
LOCKING BONE SCREW MODEL HCQ04, HCZ04
FDA 510(k)
FDA Class 2
·Orthopedic
Agilis HisPro Steerable Catheter With Electrodes
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·May 8, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007
11.0MM TI HELICAL BLADE 100MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·July 29, 2015