10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INOMAX DS
FDA 510(k)
FDA Class 2
·Anesthesiology
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NITRILE EXAMINATION GLOVES (POWERED)
FDA 510(k)
FDA Class 1
·General Hospital
2008T HEMODIALYSIS SYS., WITH CDX
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·June 26, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 6, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
ZUK ARTICULAR SURFACE PROVISIONAL
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code LXH·April 19, 2011
BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·July 3, 2019
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024