18 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLEXTIME MAGNUM 360
FDA 510(k)
FDA Class 2
·Dental
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964024625·The ENDO CARRY-ON Procedure Kit contains all of...
3D
FDA UDI
Rmo, Inc.·00885797100276·DUAL TOP MX DISTAL ARCH ASSORT
TruForm
FDA UDI
Rmo, Inc.·00885797099822·MX 1/2 BI BD KT N/L R/L 170
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 28, 2008
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code LEH·January 16, 2026
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code LEH·January 16, 2026
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 14, 2013
3100B
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC.·Product code LSZ·February 25, 2011
BD
FDA Adverse Event
BECTON DICKINSON·Product code BSP·January 30, 2008
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 3, 2012
SYRINGE 1ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 4, 2021
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·October 30, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024