9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
APTEK ULTRASOUND PROCEDURE TRAY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182239·
DIAMOND ALOE VERA, STERILE
FDA 510(k)
FDA Unclassified
·Unknown
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNIVERSAL OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·February 25, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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