12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WN SYNOCTA GOLD ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
EXCELSIOR MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 18, 2025
EXCELSIOR MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code DQY·May 18, 2010
EXCELSIOR MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DQY·August 2, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 17, 2013
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·April 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 19, 2008
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 VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024