13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CATHETER INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
KEY SURGICAL, INC.·10849771049101·K-Wires, Single trocar, .062-inch (1.6mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292763·
K-Wire w. trocar/round end 1.57mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711530·K-Wire w. trocar/round end
1.57mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484306·K-Wire w. trocar/round end _x000D_...
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D9118711530·Superb Detailing Step 3/4 mm
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYNA ZYME II GOT 340
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SCREW, FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 13, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 15, 2010
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·December 12, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 16, 2016
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