17 results · 30ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

FDA 510(k)
FDA Class 3 ·Cardiovascular

DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 2, 2026

LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

FDA Adverse Event
Injury ·ZEST ANCHORS, INC.·Product code DZE·April 25, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

LIGAURE V SEALER/DIVIDER

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 21, 2008

IMPL TAPERED SP 3.7MM 10M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

PRESIDIO 10 - CERECYTE MICROCOIL

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

PRESIDIO 18 - CERECYTE MICROCOIL

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

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