12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL CLIPPER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756364324·CNRV DIALYSIS ACCESS PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756106993·COLLES SPLINT
MRopen 0.5 T
FDA 510(k)
FDA Class 2
·Radiology
Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021
20G X 1.16IN (1.1 X 30 MM) ANGIOCATH PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 17, 2019
2124215-2012-15858
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVN·January 11, 2013
BIGLIANI/ FLATOW HUMERAL HEAD CUTTING GUIDE
FDA Adverse Event
Injury
·ZIMMER INC·Product code HSD·November 18, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 2, 2014
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
FDA Enforcement
Class II
·Ongoing·TERRAGENE S.A.·February 7, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024