17 results · 26ms · Sources: EU EUDAMED, US FDA

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PARSFIX CABLE-SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TruForm

FDA UDI
Rmo, Inc.·00885797099839·MD 1ST BI BD KT N/L UNIV 97

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022765·Wheatley's Trichrome Stain 500ml

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011003351000·Hollow chop pliers Mini, Premium Line

FLUOROTEX II SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE

FDA 510(k)
FDA Class 1 ·General Hospital

ENDEAVOR SPRINT RX

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIQ·March 14, 2013

ARCHITECT I2000SR ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·March 1, 2011

BD PARADIGAM LINK GLUCOSE MONITOR

FDA Adverse Event
Other ·NOVA BIOMEDICAL CORP.·Product code NBW·February 27, 2008

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·October 12, 2021

BD 20 ML SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 7, 2021

BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·May 28, 2019

"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

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

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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