11 results
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18ms
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Sources: EU EUDAMED, US FDA
TOUCH TALKER
FDA 510(k)
FDA Class 2
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150782·K-WIRE - SINGLE TROCAR 2.5mm DIA x 230mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450848739·
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
FDA 510(k)
FDA Class 2
·Microbiology
SCHNEIDER MAGNARAIL PROBING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 3, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·January 14, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·July 3, 2014
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 17, 2012
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·September 28, 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