13 results
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26ms
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Sources: EU EUDAMED, US FDA
MODIFIED FREEMAN REVISION ACETABULAR CUP
FDA 510(k)
FDA Class 3
·Orthopedic
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109607·DB BRACKET MINI MS MAND RIGHT CUSPID 022 TQ=-11...
LEONE SPA
FDA UDI
LEONE SPA·08033707059295·DB BRACKETS MIM EXTREMO NO-Ni 22 CEN U
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112809·BARRON VACUUM PUNCH 8.75MM
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
FDA 510(k)
FDA Class 1
·General Hospital
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BASE UNIT SERVO-U
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·October 18, 2023
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·August 28, 2024
GEMSTAR PUMP PAIN MA
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·May 2, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 8, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 10, 2010
Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016