10 results
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19ms
·
Sources: EU EUDAMED, US FDA
ZF 720
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK
S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
WIRE COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 29, 2013
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FPA·June 9, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015