14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
FDA 510(k)
FDA Class 2
·Cardiovascular
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551054277·FARRIOR Ear Speculum, size 8
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000691·
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017790·GLOBAL CAP HEAD DUOFIX HA PC SIZE 48 x 21
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053826·
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017776·GLOBAL CAP HEAD DUOFIX HA PC SIZE 48 x 18
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MAXLOCK EXTREME SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip Catheter
FDA UDI
Unisensor AG·07640172973547·
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089513111·
STABILIT INTRODUCER
FDA Adverse Event
Injury
·DFINE INC.·Product code DYB·November 26, 2008
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013