15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
DJO SURGICAL
FDA UDI
DJO, LLC·00190446953685·SPECIAL, TURON OFFSET GLENOID IMPACTOR HANDLE, ...
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·October 11, 2018
WALLFLEX DUODENAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 27, 2013
WILLIAMS CYSTOSCOPIC INJECTION NEEDLE
FDA Adverse Event
Injury
·COOK UROLOGICAL, INC.·Product code KOG·August 4, 2011
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
WALLFLEX COLONIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024
WALLFLEX COLONIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021