1,524 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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