23 results
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34ms
·
Sources: EU EUDAMED, US FDA
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317358653·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482043738·Symmetry® Scissors, Operating, Straight, Sharp/...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0360150·Modular Tip, Bifid, Cross Offset, Right
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 6, 2025
BD 10ML SYRINGE * SERINGUE LUER-LOK TIP, EMBOUTBD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·April 7, 2025
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYCLOTEC AMT CTI TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138302·Broach, 30 X 26, 15mm Height 16° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136292·Ti-6Al-4V ALIF Implant 30 X 26, 15mm Height 16°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137404·Trial, 30 X 26, 15mm Height 16° Hyperlordotic
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·March 22, 2013
CURITY 3.0MM CUFFED
FDA Adverse Event
Injury
·COVIDIEN / FORMERLY TYCO HEALTHCARE·Product code BTR·March 18, 2011
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·April 16, 2008
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 9, 2021
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
FDA Enforcement
Class III
·Terminated·Biocare Medical, LLC·June 3, 2015