20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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