17 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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