10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)
FDA 510(k)
FDA Class 2
·Dental
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
FDA 510(k)
FDA Class 2
·Cardiovascular
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
FDA 510(k)
FDA Class 2
·Microbiology
TITANIUM NEXGEN LCCL FEMORAL SZ C-LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 21, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 9, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 25, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·December 16, 2010
NEXGEN LEGACY POSTERIOR STABILIZED ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 16, 2016
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024