17 results · 21ms · Sources: EU EUDAMED, 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