9 results
·
37ms
·
Sources: EU EUDAMED, US FDA
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·April 16, 2013
PLUM XLMD PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·June 16, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 5, 2011
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015