13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUNRAY FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ArgenZ ST 98x12 ML A4
FDA UDI
ARGEN CORPORATION, THE·D818123335·Dental porcelain/ceramic restoration kit
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 33cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665023534·
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376694351·TAMP, ANGLED, SHORT
GEM OPTION FOR 1.5 MRI SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
FDA 510(k)
FDA Class 2
·Hematology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 8, 2011
SYRINGES 0.3ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 21, 2022
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026