17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601499·SPACER 2111340 OLIF25 20MM 6 DEG 12X40
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564085·CoRoent Ant TLIF PEEK, 11x11x34mm 0°
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089473960·
Experience
FDA UDI
Gc Orthodontics America Inc.·E535111340Z0101·EXZ ROTH 018/LL4 -17T 0A 4D
Experience
FDA UDI
Gc Orthodontics America Inc.·D788111340Z0101·EXZ ROTH 018/LL4 -17T 0A 4D
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 15, 2017
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 23, 2014
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 4, 2024
NI
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025