12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ASEP(TM) PLUS SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Crown cutter
FDA UDI
DFS - DIAMON GmbH·04057176151124·ZIRCUT crown cutter CA, pu: 1 pc
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150690·K-WIRE - SINGLE TROCAR 0.9mm DIA x 75mm
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
PATXFER RT
FDA 510(k)
FDA Class 2
·Radiology
IGROW II HAIR GROWTH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·December 17, 2010
KII 12X100 FIOS Z-THR HN 6/BX
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·January 30, 2013
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·July 17, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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