15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PRECIMAT(R) TRANSFERRIN
FDA 510(k)
FDA Class 2
·Immunology
GC Initial™
FDA UDI
Gc America Inc.·J0228710221·GC Initial™ LF Powder Opaq. Mod. OM-6, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556706074·GC Initial™ LF Powder Opaq. Mod. OM-6, 20g
NA
FDA UDI
KEY SURGICAL, INC.·10849771048746·K-Wires, Double trocar, .035-inch (0.9mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292374·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659483927·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 0.90mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM710220·K-Wire w. double end trocarpoint
0.90mm...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011871022000·Standard Band, Tooth 47-46/36-37, Size 22
POWDER-FREE VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Ablation Confirmation
FDA 510(k)
FDA Class 2
·Radiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 15, 2010
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·December 12, 2012
EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·August 12, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015