12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: United States
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NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
FDA 510(k)
FDA Class 1
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471129450·K-WIRE - DOUBLE TROCAR WITH GUIDE 1.6mm DIA x 1...
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GE VIVID 7, MODEL FC0003XX
FDA 510(k)
FDA Class 2
·Radiology
RELOAD FOR 60MM ECHELON
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
COMBISET WITH BVM
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·November 22, 2010
FOUNDATION SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSD·January 24, 2013
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 14, 2014
AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LPN·July 23, 2010
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LPN·July 23, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024