9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
MWI 400 WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROTECT DROPS/SAME AS K874070
FDA 510(k)
FDA Class 2
·Dental
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FUKUDA DENSHI MODEL FCP-220
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 14, 2012
BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·October 25, 2018
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024