11 results
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18ms
·
Sources: EU EUDAMED, US FDA
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
KEY SURGICAL, INC.·10849771049804·Steinmann Pins, Double diamond, 5/64-inch (2.0m...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293630·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659485020·Steinmann pin w. double end lanzet point_x000D_...
Steinmann pin w. double end lanzet point 2.0mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM716000·Steinmann pin w. double end lanzet point
2.0mm/...
ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
Renal Access Cobra Catheter, Kumpe Access Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 15, 2010
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·December 11, 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