8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
K2-HF TRANSPA orange, T-OR, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38625060·
INCORIS AL
FDA 510(k)
FDA Class 2
·Dental
PhotoFix Decellularized Bovine Pericardium
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVISA DR MRI SURESCAN
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 10, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 23, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021