23 results · 34ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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