12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PRECIMAT(R) C4
FDA 510(k)
FDA Class 2
·Immunology
NA
FDA UDI
KEY SURGICAL, INC.·10849771048753·K-Wires, Double trocar, .045-inch (1.1mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292381·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659483934·K-Wire w. double end trocarpoint _x000D_...
K-Wire w. double end trocarpoint 1.10mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM710230·K-Wire w. double end trocarpoint
1.10mm...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011871023000·Standard Band, Tooth 47-46/36-37, Size 23
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANALOG QUANTIFIER MODEL AQ-100
FDA 510(k)
FDA Class 2
·Neurology
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 8, 2010
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·December 12, 2012
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