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

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Precice® Bone Transport System

FDA 510(k)
FDA Class 2 ·Orthopedic

EarQ

FDA UDI
Oticon A/S·05707131353337·G40 S, MINIRITE 312 2.4G C044 EARQ

STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000

FDA 510(k)
FDA Class 2 ·Anesthesiology

ADVANTAGE THC TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

UNKNOWN SCS SYSTEM

FDA Adverse Event
Malfunction ·UNKNOWN·Product code LGW·August 12, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

ABS 2000

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·February 28, 2008

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·June 26, 2013

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

2250051-2008-00372

FDA Adverse Event
Malfunction ·Product code JTC·July 24, 2008

UNKNOWN GASTROJEJUNAL FEEDING TUBE

FDA Adverse Event
Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

UNKNOWN GASTROJEJUNAL FEEDING TUBE

FDA Adverse Event
Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

UNKNOWN GASTROJEJUNAL FEEDING TUBE

FDA Adverse Event
Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

UNKNOWN GASTROJEJUNAL FEEDING TUBE

FDA Adverse Event
Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·December 14, 2023

BIOLOX DELTA CER HEAD 28 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·January 21, 2016

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

FDA Enforcement
Class II ·Terminated·Allen Medical Systems·April 4, 2018

Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

FDA Enforcement
Class II ·Terminated·GE Healthcare·February 12, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021