11 results · 18ms · Sources: EU EUDAMED, US FDA

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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