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

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COLLAGEN DENTAL MEMBRANE III

FDA 510(k)
FDA Class 2 ·Dental

DRILL 1.5X105MM 22MM STP J-NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 16, 2021

DRILL 1.5X105MM 22MM STP J-NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·April 28, 2021

DRILL 1.5X105MM 22MM STP J-NT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 4, 2021

HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

ZIPPY, MODEL I88WA

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

UNKNOWN DEVICE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·April 17, 2013

ITREL

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·March 25, 2011

BD INSYTE AUTOGUARD SHIELDED IV CATHETER

FDA Adverse Event
Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·June 18, 2008

BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·October 18, 2023

G7

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·December 11, 2025

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015