17 results · 24ms · Sources: EU EUDAMED, US FDA

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Femoral Trochanteric Nail System – Neonail

FDA 510(k)
FDA Class 2 ·Orthopedic

BD BBL™ Selenite-F Broth

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210215·BD BBL™ Selenite-F Broth, 8 mL, Carton of 100 s...

FareTec PST

FDA UDI
FARETEC, INC.·B54122210210·FareTec PST, Civilian, orange, no case

Lumbar Interbody Tamp

FDA UDI
XENCO MEDICAL LLC·B064XM12210211·

Tizian Blank 5.0 translucent

FDA UDI
Pritidenta GmbH·04251366905980·

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

IQ FLEX M

FDA Adverse Event
Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

INOMAX DS (DELIVERY SYSTEM)

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

FDA 510(k)
FDA Class 2 ·Radiology

UNIFY CRT-D

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 23, 2011

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 11, 2013

LOCKING TITANIUM ADAPTER

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 12, 2024

BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

ARROW Endurance Extended Dwell Peripheral Catheter System

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023