8 results
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24ms
·
Sources: EU EUDAMED, US FDA
FETAL/MATERNAL REPEATER - 21596A
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Symmetry Goldstein
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482125700·Symmetry® Retractor, Goldstein Neck, 8 1/2 in
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
FDA 510(k)
FDA Class 1
·Radiology
ESOPHAGEAL OBTURATION AIRWAY
FDA 510(k)
FDA Class 2
·Anesthesiology
OPERA
FDA Adverse Event
Malfunction
·ARJO MED AB LTD·Product code FSA·January 14, 2014
UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·October 3, 2012
EASYTRAK
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 27, 2010
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014