14 results · 21ms · Sources: EU EUDAMED, US FDA

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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