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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Aulisa Temperature Module (TM0002)
FDA 510(k)
FDA Class 2
·General Hospital
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776413804·Cone Ring Curette, 8mm Cup, Angled 5°, 9"
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184102·Integra® Jarit® Cone Ring Curette, Angled 5°, 8...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981215767·No-Profile Interbody, 2-Hole Faceplate 20mm
MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Kontact Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 15, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2019
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
VERITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 22, 2013
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.
FDA Enforcement
Class II
·Ongoing·NuVasive Specialized Orthopedics, Inc.·November 27, 2024
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013