12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MODEL 26-0375, ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FLEXIBLE COOAGEN NERVE CUFF
FDA 510(k)
FDA Class 2
·Neurology
PARADIGMPAL, MODEL MMT-7330
FDA 510(k)
FDA Class 2
·General Hospital
SINGLE LUMEN PRESSURE MONITORING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·April 13, 2020
DELTA CER FEM HD 32/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·February 26, 2024
FEMORAL NAIL, A/R 10X340 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 9, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 28, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 14, 2014
VIVACIT-E 32MM I.D. SIZE KK NEUTRAL LINER USE WITH 56MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OQG·February 13, 2024
Pressure Monitoring Set, C-PMS, G02838
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Enforcement
Class II
·Completed·Cook Incorporated·July 20, 2022
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015