15 results · 22ms · Sources: EU EUDAMED, US FDA

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Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACTIM PROM AND CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DSC/ALF SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

3DKNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·June 6, 2013

SUMMIT POR TAPER SZ4 STD OFF

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code LPH·July 11, 2011

STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

DEKA MOTUS AX

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012