10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDISYSTEMS DIALYSIS PRIMING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mallet
FDA UDI
KATENA PRODUCTS, INC.·00841668108604·MALLET LEAD FILLED STAINLESS
MODIFICATION TO: VIPER SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sureclear aligners
FDA 510(k)
FDA Class 2
·Dental
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 31, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 27, 2011
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020