9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALICOIL SUTURE ANCHOR WITH REGENESORB
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
MONOPLUS VIOLET 1(4)150CM HRC40S LOOP(M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·April 5, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022