14 results · 23ms · Sources: EU EUDAMED, US FDA

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ENDOSCOPE REPROCESSOR OER-PRO

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LEONE SPA

FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

LEONE SPA

FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

PROMOTOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

2 PIECE MODULAR HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2022

MEDACTA KNEE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code ITI·September 16, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

NOVOTWIST 8 MM (30G)

FDA Adverse Event
Injury ·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016

CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model # LA5JL40A

FDA Recall
Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

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

Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

FDA Enforcement
Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024