20 results · 21ms · Sources: EU EUDAMED, 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