14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDEAL 1 ORTHODONTIC BAND CEMENT
FDA 510(k)
FDA Class 2
·Dental
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503188·Leksell MPS Arc w Counter Scale - ARC ATTACHMEN...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128879·15-20 MV FOR MEN CLSC EW STD NAVY V
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101833·SS Suture, 5 per sleeve
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476125·
RANDOX CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THE NURTURE III BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 3, 2013
PERPOS PLS
FDA Adverse Event
Malfunction
·INTERVENTIONAL SPINE, INC.·Product code HXX·February 15, 2011
PERFUSOR BASIC
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·May 7, 2008
BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024