18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Belun Ring BLR-100X
FDA 510(k)
FDA Class 2
·Cardiovascular
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003447·Luna Opal R Mini .018 Kit 3x3 U Hooks
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113379·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981027797·Transverse Hook Small. The Coral Spinal System ...
Stainless Steel
FDA UDI
Seaspine Orthopedics Corporation·10889981028466·Transverse Process Hook Medium. The Stainless S...
BD BBL¿ MANNITOL SALT AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·December 16, 2021
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
FDA 510(k)
FDA Class 1
·General Hospital
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164436·BLACKHAWK,STERILE,LORDOTIC,14X12X7
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 28, 2023
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025