18 results · 36ms · Sources: EU EUDAMED, 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