17 results
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20ms
·
Sources: EU EUDAMED, US FDA
STETHOFLUX
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00600641·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312070·GLENOID RESURFACING REAMER Ø24mm WITHOUT DRILL ...
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631557·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631564·
SELOX SR 45
FDA Adverse Event
Other
·BIOTRONIK GMBH CO·Product code DTB·June 29, 2006
SELOX SR 53
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO·Product code DTB·June 29, 2006
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
FDA 510(k)
FDA Class 2
·Hematology
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
FDA 510(k)
FDA Class 2
·Radiology
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
PALINDROME SAPPHIRE 23/40KT VT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·March 20, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 12, 2008
2124215-2011-06187
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVY·April 15, 2011
NON-VENTED HOSPITAL FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018