14 results
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21ms
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Sources: EU EUDAMED, US FDA
FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
FDA 510(k)
FDA Class 2
·Dental
STERILE NITRILE SURGICAL GLOVES (POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOMESH P1 AND BIOMESH PLUG AND PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 28, 2021
NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·July 20, 2022
NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·July 9, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·April 21, 2011
INSYNC II MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·July 10, 2008
NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 11, 2024
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 28, 2024
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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