17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALAB URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNIVERSAL DENTAL COPING (UDC)
FDA 510(k)
FDA Class 2
·Dental
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400404670·C & B FORMULA 4 OZ SHADE 67
NAMILON POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI200404670·NAMILON POWDER 4 OZ SHADE 67
PYROPLAST POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI100404670·PYROPLAST POWDER 4 OZ SHADE 67
PARADIGM SURE-T
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 9, 2014
THREE PEG PATELLA 35MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 26, 2024
LOGIC RBK INSERT SZ 2.5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
CORAIL2 STD SIZE 14
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS 3003895575·Product code KWA·April 15, 2019
12/14 ARTICUL 40MM M SPEC+5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 15, 2019
STELLARIS 25GA POSTERIOR PACK W AFI AND WF
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013
HYLAMER 10D 66OD X 32ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 8, 2008
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 5, 2011
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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