15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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