11 results · 24ms · Sources: EU EUDAMED, US FDA

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CONFIDENCE FENESTRATED INTRODUCER NEEDLE

FDA 510(k)
FDA Class 2 ·Orthopedic

FRIALOC DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

CALEO

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

ISA CO2

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 27, 2013

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 11, 2011

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME CORPORATION·Product code MOZ·June 19, 2008

ARROW PSI SET: 8.5 FR

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code DYB·April 4, 2022

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