15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032861·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm B...
West Pharmaceutical Services Arizona, Inc.
FDA registration
West Pharmaceutical Services Arizona, Inc.·1 product·🇺🇸 United States
VASCUPUNCTURE ACCESS WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
FDA 510(k)
FDA Class 2
·General Hospital
CORTICAL BONE SCREW 5.0MM X 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·August 21, 2013
HFN LH 125 DEG 13MM X 420MM NAIL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·August 21, 2013
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
EQUIPO ADMON SOL PEEL POUCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·March 29, 2011
TA 45-4.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·April 22, 2008
EMBOSHIELD NAV6
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code NTE·January 26, 2024
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
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