21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electrical Scooter, WT-T4SU
FDA 510(k)
FDA Class 2
·Physical Medicine
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD
devemed
FDA UDI
devemed GmbH·04061644032945·Applicator | 135 mm
for bone grafting material
...
Reicodent
FDA UDI
devemed GmbH·04061644063376·Applicator | 135 mm
for bone grafting material
...
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 21, 2018
NA
FDA UDI
STRYKER CORPORATION·07613327053883·Cutting Loop Electrode, .014 wire, 24 Fr ¿ 90 ¿
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
ASTROGLIDE SENSUAL STRAWBERRY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
OLYMPUS EVIS EXERA II
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDS·August 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 16, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·June 27, 2018
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·June 27, 2018
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025