17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CUTTERSIL MUCOSA
FDA 510(k)
FDA Class 2
·Dental
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909101652·REVELATION DIAMOND 806-012C - 5 PACK
MyndMove
FDA UDI
MyndTec Inc·06925209101652·
MyndMove
FDA UDI
MyndTec Inc·00692520101659·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349789·EXTREMITY PACK
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373483·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373490·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373476·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Bone Screws
FDA UDI
ORTHOFIX SRL·18033509850394·CORTICAL SCREW 150/40 MM STERILE SHAFT D 6 MM ...
ERO SCAN OAE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FREERIDER MODEL LUGGIE MODEL 168-4IT
FDA 510(k)
FDA Class 2
·Physical Medicine
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 30, 2010
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 2, 2014
SECURE II MED/ SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 19, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024