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

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VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Bosworth TruRepair

FDA UDI
Harry J Bosworth Company·H6680921711·1 Qt Repair Liquid

INVACARE LIFT CHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

FDA 510(k)
FDA Class 2 ·Cardiovascular

HAHN TAPERED IMPLANT Ø3.5 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 27, 2025

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·September 21, 2009

ECAREMANAGER V3.6

FDA Adverse Event
Malfunction ·VISICU·Product code MSX·December 14, 2009

FORTIFY DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 3, 2013

FUSION NAVIGATION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 27, 2011

NONIN

FDA Adverse Event
Other ·CAREFUSION 211, INC.·Product code DQA·December 13, 2010

HAHN TAPERED IMPLANT 03.5 X 10MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 15, 2022

HAHN TAPERED IMPLANT Ø3.5 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 19, 2022

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024