23 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUVUE (senofilcon C) Soft Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524842·GUIDE 2160212 ALIF SCREW GUIDE 12MM
Diamond Burr
FDA UDI
ELLIQUENCE, LLC·00846338003913·
Orthocryl®
FDA UDI
DENTAURUM GmbH & Co.KG·J011160212000·Orthocryl® powder, clear/ orthodontic acrylics
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023957·B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 50 MM
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973106425·TRIAL 90-SRK-160212 POLY CR 2X12MM
NA
FDA UDI
aap Implantate AG·04042409037894·Drill guide insert, CS 2.7-4.0
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 8, 2016
DENTACENTER/EXPEDITION, MODEL SAF-430
FDA 510(k)
FDA Class 1
·Dental
MERITS MODEL E SERIES LIFT CHAIRS
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 3, 2020
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 11, 2003
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 2, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OLO·June 10, 2025
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 10, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 19, 2014
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·June 2, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 29, 2018
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 1, 2012