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

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Magic 360 Power Wheelchair

FDA 510(k)
FDA Class 2 ·Physical Medicine

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 24, 2022

AGILIS ES STEERABLE INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

FDA 510(k)
FDA Class 2 ·General Hospital

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 4, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

REVEAL XT

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DSI·August 11, 2011

ULTRASONIC IMAGING CATHETER - CORONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·July 2, 2013

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

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

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

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021