14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
FDA 510(k)
FDA Class 1
·General Hospital
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674882·
SKELITE RESORBABLE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERMASHADE VENEER CEMENT
FDA 510(k)
FDA Class 2
·Dental
1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN.
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 25, 2022
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWP·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017