17 results · 27ms · Sources: EU EUDAMED, 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