16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Endoscopic Camera System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Nexa3D
FDA UDI
Keystone Industries·H66852233011·KeySplint Hard for Nexa3D, 5 kg
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776384128·Smith-Petersen Osteotome, 8", straight, 3/4"
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154750758·Bone Screws, MP, Cross-Pin
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930980·BIT, HEX FEMALE 8.0MM 1/4 SQ
ERBE VIO 300 D
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·August 8, 2025
LEONE SPA
FDA UDI
LEONE SPA·08033707100881·MINI HYBRID MODE EXP. 2 ARMS 4MM 600G
.
SYNTHES RAPID RESORBABLE TACK SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·September 15, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Plus Initial Drill, Article Number: 103.170;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·June 4, 2025
Arrow Three-Lumen CVC
FDA Enforcement
Class II
·Terminated·ARROW INTERNATIONAL Inc.·July 6, 2022
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020