14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DIASORIN LIAISON VZV IGG
FDA 510(k)
FDA Class 2
·Microbiology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0618200·6mm H x 18mm W x 20mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06182080·6mm H x 18mm W x 20mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L061820120·6mm H x 18mm W x 20mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X061820120·6mm H x 18mm W x 20mm L x 12 degrees XLIF
DENTORIUM CONVERTIBLE ACRYLIC
FDA 510(k)
FDA Class 2
·Dental
AART SILICONE CARVING BLOCK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code LRN·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 30, 2011
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 13, 2008
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024