17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Apex Revision Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
US ENDOSCOPY CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EKOS MICRO-INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 8, 2014
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 8, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 21, 2011
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 7, 2020
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016