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