32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER-FREE BLUE VINYL EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ECHOSTAR COMFORT 1.5T MRI
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 22, 2021
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 30, 2019
*
FDA Adverse Event
Malfunction
·OHIO MEDICAL CORPORATION·Product code JCX·November 12, 2008
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 2, 2018
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 2, 2026
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026
PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·October 15, 2025