17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ulthera System (UC-1 Control Unit PRIME Model 2.1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813057803·STERILE CARBIDE BUR FG330S DARBY
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780384526·Integra® Jarit® Kiene Bone Tamp, 6", 10mm Diameter
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154997641·Bone Screws w. increased head,Cross Pin
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981310394·No-Profile Interbody, 4-Hole Faceplate 18mm
TISSUE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIVIX-S VW
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
aap Implantate AG·04042409445125·Cannulated Headless Bone Screw 2.5, L 18, TL 4 ...
VENTRASSIST
FDA Adverse Event
Injury
·VENTRACOR·Product code DSQ·November 24, 2008
MICROSTAAR® INJECTOR CARTRIDGE
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code KYB·September 15, 2011
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·July 26, 2013
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 20, 2017
GS CORPATCH
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·January 27, 2026
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 18, 2018
SENSOR MMT-7040C5 GUARDIAN4 5PK OUS 5
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·September 2, 2025
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
FDA Enforcement
Class II
·Ongoing·Preat Corp·August 28, 2024
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