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

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TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

UCSS SCREW SET

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

UCSS SCREW SET

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

UCSS

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

UCSS SCREW SET

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

UCSS SCREW SET

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

GUIDE, SURGICAL, INSTRUMENT

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021867·Unitary Specimen Tubes

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159003925·S LEGACY Mic fcp, RH, NS DG, str 1.0 mm DD pfrt...

SIGMA

FDA 510(k)
FDA Class 2 ·Dental

QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)
FDA Class 2 ·Microbiology

BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·August 12, 2019

TANDEM T: SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES·Product code LZG·March 12, 2013

ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code DQX·March 1, 2011

OUT PATIENT REGU-GAGE

FDA Adverse Event
Malfunction ·ALLIED HEALTH CARE PRODUCTS, INC.·Product code GCX·January 31, 2008

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·August 12, 2019

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

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