18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SaliPen
FDA 510(k)
FDA Class 2
·Dental
VariAx
FDA UDI
Stryker GmbH·37613153067741·LOCKING PEGS
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037317990·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...
36M - Marathon Petroleum LS Terminals - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588206189·36M - Marathon Petroleum LS Terminals - Metal
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113409·PS Insert, Size 6 x 18mm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220618000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220618150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220618070·
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code FMF·May 3, 2024
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·December 4, 2019
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021