26 results · 24ms · Sources: EU EUDAMED, US FDA

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IO-FLEX CATHETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

FDA 510(k)
FDA Class 1 ·General Hospital

ELECSYS TROPONIN I CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

2.4MM VA LOCKING SCREW STARDRIVE 22MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·June 25, 2013

VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 1, 2013

ESPRIT VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 19, 2014

PIN COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·May 20, 2011

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 5, 2019

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 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

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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