11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X-Twist PEEK Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111328503·IRIS SCISS DEL STR S/S 3 1/2"
BALLARD™
FDA UDI
SUNMED, LLC·10889483564394·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Elbo...
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038989884·BALLARD* Closed Suction Catheter, T-Piece
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 10, 2002
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 23, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 11, 2013
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025