14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES DUAL-OPENING USS
FDA 510(k)
FDA Class 2
·Orthopedic
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160449·Channels Flex Assorted Pack 31mm .04 Taperx....
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062291·Mini Uni-Twin(TM) Bracket APC(TM) II Sondhi UL3...
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717106897·Paper Points, Taper .04, Size #55, 100pcs/box
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093318·Mini Uni-Twin(TM) Bracket APC(TM) PLUS Sondhi U...
USS VAS
FDA 510(k)
FDA Class 2
·Orthopedic
LIFE SCOPE EC, MODEL BSM-1102
FDA 510(k)
FDA Class 2
·Cardiovascular
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 27, 2024
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 31, 2007
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC·Product code OTN·March 26, 2013
SIMPLEX P - US FULL DOSE 10-PK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·February 16, 2011
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018