15 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIRAGE QUATTRO FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
35A-IT Incubator Transporter
FDA UDI
FERNO-WASHINGTON, INC.·00190790001131·35A-IT Incubator Transporter, MKII
Sklar®
FDA UDI
SKLAR CORPORATION·40649111184155·DISP SCALPEL STER #22 BOX/10
EMS ELECTROSTATIC FLITER AND HME COMBINATION
FDA 510(k)
FDA Class 2
·Anesthesiology
SMARTFLOW, MODEL SFIP 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
HANDLE WITH MINI QUICK COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWX·February 19, 2021
HOSPITAL NON-VENTED FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 17, 2013
COOL PATH 7F, 1304-CP-7-25-M
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·March 22, 2011
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MKN·June 20, 2008
MOZAIK
FDA Adverse Event
Injury
·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 20, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
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