17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PathLoc-C Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
NEO ERCP GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
FDA 510(k)
FDA Class 2
·Immunology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
VERCISE®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2014
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code MHY·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
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 7, 2020
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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