12 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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HEALTHY SLEEP APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491923·BONE SCREW, CROSS-PIN
NEUFLEX
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017950·NEUFLEX MCP FINGER IMPLANT 10 CEMENTLESS
ROCCIA
FDA UDI
Silony Medical GmbH·04054896028224·ROCCIA MultiLIF Cage 12 x 34 mm, 10° Lor.
NEOPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025