20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
FDA Enforcement
Class II
·Terminated·Monteris Medical Corp·November 26, 2014
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113249·PS Insert, Size 4 x 14mm
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355639·Bone Screws, Cross-Pin
Dale Peripheral Vascular Clamp 18.5cm
FDA UDI
Geister Medizintechnik GmbH·04057034055793·Dale Peripheral Vascular Clamp 18.5cm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220414070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220414000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220414150·
QUANTA LITE CCP ELISA
FDA 510(k)
FDA Class 2
·Immunology
OSSEOSPEED PLUS
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·October 31, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 23, 2011
INTERTAN 10S NAILS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDS·July 11, 2013
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012