17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ELEVATE™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169430778·SPACER 8880823 ELEVATE X-LOR 23X8MM
Sasmar Pina Colada
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008235·PERSONAL LUBRICANT
CONTACT LENS CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 9, 2014
ZIMMER DERMATOME BLADE
FDA Adverse Event
Malfunction
·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code GFD·October 1, 2010
TI MATRIX LOCKING CAP
FDA Adverse Event
Death
·SYNTHES BRANDYWINE·Product code NKB·December 20, 2012
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·May 20, 2024
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·January 30, 2025
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MAX·July 31, 2023
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·August 5, 2024
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·May 20, 2025
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020