15 results · 23ms · 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.

REGAIN DESKTOP

FDA 510(k)
FDA Class 2 ·Neurology

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00531271·

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964021334·The ENDO CARRY-ON Procedure Kit contains all of...

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

FDA 510(k)
FDA Class 2 ·Ophthalmic

ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Immunology

BD PHASEAL PROTECTOR (P55)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·December 10, 2020

BIO-CORKSCREW SUTURE ANCHOR

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·June 26, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

HIRES 90K

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·February 15, 2011

SYRINGE 5ML EMERALD BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 30, 2019

TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

FDA Enforcement
Class II ·Ongoing·Acclarent, Inc.·December 29, 2021

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

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