9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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W&H Implantmed SI-1015 incl. Accessories
FDA 510(k)
FDA Class 1
·Dental
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 10, 2024
POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 11, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 24, 2014
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code LZS·May 17, 2011
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 25, 2019