10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
FDA 510(k)
FDA Class 2
·Immunology
BD INTIMA II¿ IV CATHETER
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·February 15, 2018
HNM LATERAL ANCHOR
FDA Adverse Event
Injury
·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 26, 2011
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 6, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025