1,524 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008157·Zirlux 16+ A2 89x17x14
OsteoMed
FDA UDI
OSTEOMED LLC·00845694091282·2.0mm x 18mm Fully Threaded Screw
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369395·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369449·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369418·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369425·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369432·
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967186887·Battalion, LLIF Trial, 10°, 20 mm Wide, 18 mm X...
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033369401·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
NDO SURGICAL SURGICAL OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISTAKON (HEFILCON C) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
SENSICA UO MONITOR ICU
FDA Adverse Event
Malfunction
·ADAPTEC MEDICAL DEVICES LLC 3014271001·Product code EXS·November 22, 2019
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
FDA Enforcement
Class II
·Terminated·Reshape Medical Inc·November 16, 2016
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER,TUBING
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 10, 2018
SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 5, 2019
NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·March 1, 2018
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS LLC·Product code OYC·June 8, 2018
INTROCAN SAFETY
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FOZ·September 17, 2013