31 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Goblin and Goblin LS Pedicle Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780065616·The standard Kompressor Compression Screw is a ...
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185336·AccuFit™ Molar Band UL7 - 42
PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023
OPHIRA MINI SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUSCH MMG/O'NEIL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·April 9, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 8, 2021
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2025
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·July 11, 2025
MYSPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·September 27, 2024
BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 16, 2021
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·June 5, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 12, 2011
FORTIFY ASSURA DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
PEDICLE SCREW MUST MC SCREW Ø6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·December 21, 2022
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems. It is used to intravenously facilitate the administration of contrast media and flushing solutions into the human vascular systems.
FDA Enforcement
Class II
·Terminated·Bracco Injeneering S.A.·December 26, 2018