16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Admira Fusion Flow
FDA 510(k)
FDA Class 2
·Dental
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 4, 2021
Persona Knee System
FDA UDI
Zimmer, Inc.·00889024485785·
COMPLETE D 25-OH VITAMIN D CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
FDA 510(k)
FDA Class 2
·General Hospital
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 14, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·June 8, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 23, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code MSF·September 4, 2008
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 31, 2016
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X9 L5°
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·March 2, 2017
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023