10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPREGUM PENTA
FDA 510(k)
FDA Class 2
·Dental
icotec Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
LAP LOOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·May 7, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·October 12, 2022
NOTINGHM SHLDR HUM HEAD 48X17 OFFSET
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·January 19, 2016
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·March 2, 2013
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
TERUMO CDI 101 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·February 4, 2011
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026