14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LessRay with Tracking
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619047290·Thermoset™ Probe
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613107673·House Elevator, Narrow, 3mm Straight Blade, Ove...
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 13, 2023
MICROALBUMIN MULTI-CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BARLE TISSUE ADHESIVE 2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIKORAIL 142/243/250
FDA Adverse Event
Death
·HILL-ROM COMPANY/LIKO AB·Product code FSA·July 22, 2014
UNK ELECTRODE
FDA Adverse Event
Other
·COVIDIEN·Product code GXY·May 24, 2013
DORADO BALLOON DILATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
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