17 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BD BACTEC Peds Plus/F Culture Vials (plastic)
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00887868267208·
ORTHOPEDIC SALVAGE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304688001·
PREMIER TEMPORARY CEMENT
FDA 510(k)
FDA Class 2
·Dental
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER SST II ADVANCE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·June 22, 2021
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 10, 2024
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL, NEUROMODULATION·Product code GZB·October 6, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 7, 2013
BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·June 1, 2021
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
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
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