20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ProCopper
FDA UDI
SILMET LTD·07290012207778·Dental Amalgam
ACIER
FDA UDI
PETERS SURGICAL·03661522028131·
ARGENCO W (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120245·Alloy other noble metal
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007515·SOSOFT 8-15 MM HG KNEE HIGH BROCADE LARGE WHITE...
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376526812·CoCr Straight Rod, 4.5mm X 500mm
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031527·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970386·
HS/HG PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
PROCEED VENTRAL PATCH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 3, 2019
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 3, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 3, 2019
SIELLO S 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·August 29, 2023
Truliant
FDA UDI
Exactech, Inc.·10885862314819·Truliant PS Porous Femoral
100MM MONOPOLAR NITINOL ELECTRODE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GXD·May 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·August 14, 2008
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015