19 results · 25ms · Sources: EU EUDAMED, US FDA

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CaP Spheres Pellet Pack

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)

COMET COSMIC 203/218

FDA 510(k)

STERRAD CHEMICAL INDICATOR STRIP

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO PLEXOLONG SETS

FDA 510(k)
FDA Class 2 ·Anesthesiology

INTERSTIM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 17, 2008

KAPPA 900 DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

BREG POST OP SHOE

FDA Adverse Event
Malfunction ·BREG, INC.·Product code IQI·July 2, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

BD PHASEAL¿ INFUSION ADAPTER C100

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·April 11, 2023

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024